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QA Chemist (Hillerød, Denmark)

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QA Chemist

- Quality
- Denmark - Hillerød

Do you want to be part of Quality Assurance and ensure a high level of quality of Novo Nordisk’s insulin products and hereby make a difference for thousands of people? In QA Finished Products (FP) we are looking for a talented and ambitious QA chemist, with a desire to work in our FP production in Hillerød.

About the department
The new position is an expansion so that we are ready to ensure the quality level in 2014. You will join a dynamic department of 31 employees, divided into three teams; two in FP and one in the Aseptic Production (AP). You will join one of the FP teams, which consist of 8 highly skilled colleagues from different professional backgrounds.

You will become part of an ambitious team with an informal relation, good humour and where we take care of each other, and in that way you will rapidly, as a new employee, become a part of the team.

The Job
The team is responsible for assuring that systems and processes in relation to FlexPen® and the Quality Control (QC) area are in compliance with GMP requirements, and at the same time, act as compliance support to our production teams.

We work in a fast pace and our key tasks are review and approval of all types of GMP documentation; such as batch, change requests, non-conformities and validation reports all this with the common goal of releasing insulin products to our customers.

On top of that, QA is an important player at internal audits and external authority inspections, where you are expected to participate and present data when needed.

In this fast paced and dynamic environment, prioritisation can quickly change, whereby no days are the same and you will constantly be challenged, both in regards to the complexity of the tasks but also on tight deadlines.

Being a new member of the team, you will undergo a structured and individual training program with one of your colleagues acting as the trainer, and you can expect increasingly more responsibility. Subsequently, you will have an individual development plan to ensure continuous development and realization of your potential.

Qualifications
You hold an academic degree, e.g. pharmacist, veterinarian, biochemist, or similar. GMP experience or work experience from the pharmaceutical industry is preferred, but it is not a requirement.

Most importantly; you thrive in a fast-paced environment where you can take the lead and set directions in order to achieve business goals and at the same time you never compromise on quality, authority demands or deadlines. You are structured and a good coordinator and know how to prioritise between different quality tasks - All this with a positive mind-set.

Finally, you can communicate in both Danish and English written as well as spoken.

Feel free to submit your job application, as quickly as possible, in either English or Danish.

You can learn more about working as QA in Novo Nordisk by clicking on this link: www.novonordisk.com/careers/QA

At Novo Nordisk, we strive for excellence. As a world leader in diabetes care and a major player in haemostasis management, growth hormone therapy and hormone replacement therapy, we offer our employees opportunities for continuous growth.

Contact
For further information, please contact Heidi Bisgaard Jensen on phone + 45 3075 3147.

Deadline
17 December 2013

Kemiker til stabile produktionsprocesser for HPLC-kolonner (Køge, Danmark)

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Kemiker til stabile produktionsprocesser for HPLC-kolonner

- Produktion
- Danmark - Køge

Vi har brug for din hjælp i en periode på 9-10 måneder.

Vil du anvende og udvikle dine professionelle kemiske og projektfaglige færdigheder i et samarbejde omkring stabile produktionsprocesser og levering af HPLC-kolonner til analyse af lægemidler?

Er du positiv, engageret og fleksibel, og trives du med en omskiftelig hverdag, hvor fokus sættes ud fra kundernes behov? Vi tilbyder en spændende arbejdsplads med skiftende udfordringer, hvor du kan opnå god erfaring med kolonneproduktion/stabilisering af produktionsprocesser. Du vil blive en del af et team i udvikling med fokus på faglighed, engagement og quality mindset.

Om afdelingen
FeF Chemicals A/S er et 100% ejet datterselskab af Novo Nordisk A/S og ligger i Køge. I dag er vores største produktgruppe substitueret kiselgel, der bruges til kromatografisk oprensning af Novo Nordisks lægemidler. Desuden producerer vi kvaternære ammoniumforbindelser, som vi markedsfører over hele verden. Vi er i dag ca. 140 ansatte i firmaet. Udviklingsafdelingen består af 6 kemikere og 12 laboranter fordelt på 3 teams. Vi er kompetencecenter for gelteknologi i Novo Nordisk, hvilket indebærer en tæt kontakt til forsknings-, udviklings- og produktionsafdelinger i koncernen.

Du bliver en del af Kolonnepak-teamet, som består af 3 laboranter, 3 kemikere og en teamleder. Teamet producerer analytiske HPLC-kolonner til analyse af lægemidler og brug i udviklings-, produktionsudvikling- og analyseafdelinger i Novo Nordisk og FeF.

For at stabilisere kolonneproduktionen gennemfører vi udviklingsprojekter, baseret på laboratorieforsøg. Vi fremstiller kromatografiske faser ved organisk syntese med kiselgel og producerer kolonner under ISO9001. Såvel udvikling som produktion dokumenteres, ligesom projektfremdrift rapporteres løbende.

Jobbet
Dit job bliver at sikre stabile produktionsprocesser og dokumentation herfor, så teamet kan levere HPLC kolonner i rette kvalitet til tiden. Du skal opbygge og forankre anvendt og videnskabelig vide n om kromatografiske kolonnematerialer og produktion af kolonner.

Arbejdet vil hovedsagelig bestå i at designe, planlægge og rapportere samt evt. i mindre omfang at udføre og dokumentere laboratoriearbejde.

Du vil i samarbejde med kemikere og laboranter blive ansvarlig for kemiske udviklingsforsøg med geler og kolonner/arbejde med forskellige produktionsprocesser. Du vil planlægge, drive, gennemføre og dokumentere stabile produktionsprocesser for HPLC-kolonner, herunder rapportere projektfremdrift.

Kvalifikationer
Du er uddannet cand.scient i kemi, kemisk ingeniør eller lign., gerne med en Ph.D., og med indsigt og viden om kemiske reaktioner og kromatografi. Du har mere end 3 års kemisk laboratorieerfaring indenfor organisk syntese og HPLC-analyse og har en skarp analytisk sans. Du er dygtig til at opbygge viden, vidensdele, dokumentere og afrapportere laboratorie- og projektarbejde. Det er en fordel, hvis du har erfaring med dokumentation (ISO/GMP).

Du bidrager med dine kemiske færdigheder på højt niveau omsat til praksis. Din tilgang er analytisk og databaseret.

Du leder projekter og implementerer forbedringer ved brug af statistiske værktøjer og forsøgsdesign (DOE) i tæt samarbejde med kolleger og kunder.

Du holder overblik og hjælpe med at prioritere opgaver, ligesom du koordinerer med interessenter. Du udarbejder udviklingsrapporter og anden videnskabelig, teknisk og kvalitetsmæssig dokumentation.

Som person har du let ved at omgås kolleger på alle niveauer i organisationen, og du gør dit for at bidrage til den positive stemning i teamet. Du tager ansvar for, at vi både som team og individer, når de mål forretningen har brug for. Du forstår betydningen af kundefokus og opbygger gode relationer til samarbejdspartnere. Du kan lide at tage ansvar og vise vejen, samtidig med at du som teamspiller har fokus på at spille andre stærke.

Hvis du er indstillet på at dokumentere levering af HPLC-kolonner og stabile produktionsprocesser, kan vi tilbyde dig samarbejde med kompetente og engagerede kolleger og mulighed for professionel og personlig udvikling. Arbejdet foregår i en uformel atmosfære, hvor vi har fokus på som team at levere i rette kvalitet til vores kunder.

Kontakt
Vil du vide mere om stillingen, er du meget velkommen til at kontakte Kirsten Modvig på telefon 2429 4119

Ansøgningsfrist
6. januar 2014

Postdoctoral Researcher (Greater Copenhagen area, Denmark)

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Postdoctoral Researcher

- Research & Development
- Denmark - Greater Copenhagen area

An international Postdoctoral position in the field of functional genetics in multiple sclerosis is available for a highly skilled scientist in collaboration between Novo Nordisk Research Center Seattle, US and the Nuffield Department of Clinical Neurosciences, Clinical Neurology, University of Oxford, United Kingdom.

About the department
The project will mainly be performed in the laboratory of Professor Lars Fugger, University of Oxford, where the Postdoctoral Researcher will join a team of scientists and clinicians with a range of genetic, immunological and neurological expertise to work in an interdisciplinary environment in which research, teaching, clinical training and clinical care interact. The University of Oxford is a stimulating organisation, which enjoys an international reputation as a world-class centre of excellence in research and teaching.

The Novo Nordisk Research Center Seattle is home to the company’s Inflammation R&D Centre where researchers leverage Novo Nordisk’s strong knowledge within the field of proteins, in order to further build the company’s clinical pipeline of products for the treatment of chronic inflammatory diseases. Globally, about 6,000 Novo Nordisk employees are involved in research and development activities with main R&D facilities located in the Copenhagen area (Denmark), Beijing and Seattle.

The Job
The project will focus on elucidating the functional basis of selected genetic variants identified in multiple sclerosis GWAS using a combination of genetic, biochemical and immunologic approaches.

The overall goal of the project is to apply genetic approaches towards improved disease treatment of multiple sclerosis and potentially other autoimmune diseases.

The candidate will be employed by Novo Nordisk. However most of the work will take place in the laboratory of Professor Lars Fugger, University of Oxford, and a minor part in the Novo Nordisk Research Center Seattle. Visits to the Novo Nordisk research headquarter in Denmark will also occur. The candidate must therefore expect some extent of travelling between these locations.

The position is for a fixed-term period of two years and is available as soon as possible. The recruitment process will be conducted in cooperation between Novo Nordisk and University of Oxford.

The position is offered as part of the Novo Nordisk R&D STAR Programme (Science, Talent, Attraction and Recruitment). This programme supports the brightest graduate students in biotechnology, life, medical and engineering sciences, who want to pursue a career in pharmaceutical R&D.

Qualifications
A PhD in Immunology is essential, with up to 3 years postdoctoral research experience. Prior research experience investigating the immunological and/or genetic association of an autoimmune disease would be highly advantageous.

The successful candidate must have excellent English language skills and be able to

communicate results clearly as demonstrated by both oral presentation and publication history. A keen willingness to show initiative in developing novel techniques and strategies to achieve research goals is also required.

At Novo Nordisk, we strive for excellence. Your curiosity, skills, dedication and ambition will help us change lives for the better. We offer you an opportunity to work in an extraordinary stimulating scientific environment.

Contacts
If you would like to know more about the position please contact Jacques Peschon by email, JQPS@novonordisk.com

Deadline
14 January 2014.

QA Proffesionals (Bagsværd, Denmark)

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QA Proffesionals

- Quality
- Denmark - Bagsværd

Do you want a key role in ensuring the quality of the insulin products and compliance with regulatory requirements? If so, then seize the opportunity and join QA of the aseptic production (AP) in Bagsværd, Site Denmark.

About the department
In QA AP we are responsible of assuring quality and compliance in the AP of insulin products in Bagsværd, Site Denmark. It is our responsibility that the documentation related to AP is in compliance with regulatory requirements and the Novo Nordisk quality management system.

In QA AP you will join a department of 40 highly motivated and dedicated employees which is divided in three teams, Operation (review of batch documentation and approval of reports related to daily operations), Aseptic Production (release of batch to next process, approval of incidents and SOP related to daily operation) and Projects (approval of change request and validation documentation, implementation of new products). In a close collaboration with the production we ensure a high level of quality and play a key role in releasing insulin products to diabetics all over the world. We are at the moment looking for a QA Professional (permanent position) to our Aseptic Production Team.

The Job
As a QA professional you will be a decisive factor in making sure that the released products lives up the current GMP and regulatory requirements. You will be involved in the handling of incidents in the production and participate in systematic problem solving together with process support and production. Likewise, you will perform different tasks related to quality assurance, e.g. approval of batch documentation and production related documents. We operate in a LEAN environment where we focus on optimising our processes. You will therefore be involved in the implementation of new initiative which can optimise our daily work.

Qualifications
You hold an academic degree and preferably your academic background is topped with at least one year of relevant experience from the pharmaceutical industry. On a personal level you are known for you positive mindset, flexibility and persistence. You have a strong quality mindset, meet your deadlines, and know how to prioritise between different tasks in a dynamic environment. You like and are good at coordinating different tasks for both yourself and other people and you demonstrate an ability to find the right solutions with your colleagues. Your language skills cover proficiency in both Danish and English.

Your application and CV is welcome in Danish or English.

At Novo Nordisk, we strive for excellence. As a world leader in diabetes care and a major player in haemostasis management, growth hormone therapy and hormone replacement therapy, we offer our employees opportunities for continuous growth.

Contact
For further information, please contact Henriette Kyed at +45 3075 2194.

Deadline
31 December 2013

QA proffesional (Bagsværd, Denmark)

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QA proffesional

- Quality
- Denmark - Bagsværd

Do you want a key role in ensuring the quality of the insulin products and compliance with regulatory requirements? If so, then seize the opportunity and join QA of the aseptic production (AP) in Bagsværd, Site Denmark.

About the department
In QA AP we are responsible of assuring quality and compliance in the AP of insulin products in Bagsværd, Site Denmark. It is our responsibility that the documentation related to AP is in compliance with regulatory requirements and the Novo Nordisk quality management system.

In QA AP you will join a department of 40 highly motivated and dedicated employees which is divided in three teams, Operation (review of batch documentation and approval of reports related to daily operations), Aseptic Production (release of batch to next process, approval of incidents and SOP related to daily operation) and Projects (approval of change request and validation documentation, implementation of new products). In a close collaboration with the production we ensure a high level of quality and play a key role in releasing insulin products to diabetics all over the world. We are at the moment looking for a QA Professional (permanent position) to our Project Team.

The Job
As a QA project professional you will be a decisive factor in making sure that the validations and related documents lives up the current GMP and regulatory requirements. You will be involved in projects in the production unit when new equipment and new products is implemented. Like you will approve when changes to the facility is performed. Your close stakeholders will be a broad network of people from new product entry and production.

You will be involved in the handling of incidents in the production and participate in systematic problem solving together with process support, technical support and production. We operate in a LEAN environment where we focus on optimising our processes. You will therefore be involved in the implementation of new initiatives which can optimise our daily work.

Qualifications
You hold an academic degree and your academic background is topped with at least 5 years of relevant experience from the pharmaceutical industry working with validations and projects.

You have specific work experience with validation of equipment or validation of production processes and have worked with risk assessment.

On a personal level you are known for you positive mindset, flexibility and persistence. You have a strong quality mindset, meet your deadlines, and know how to prioritise between different tasks in a dynamic environment. You like and are good at coordinating different tasks for both yourself and other people and you demonstrate an ability to find the right solutions with your colleagues. Your language skills cover proficiency in both Danish (fluent) and English.

Your application and CV is welcome in Danish or English.

At Novo Nordisk, we strive for excellence. As a world leader in diabetes care and a major player in haemostasis management, growth hormone therapy and hormone replacement therapy, we offer our employees opportunities for continuous growth.

Contact
For further information, please contact Henriette Kyed at +45 3075 2194 or Jane Hagan at +45 3079 2497.

Deadline
31 December 2013

Process Supporter (Måløv, Denmark)

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Process Supporter

- Production
- Denmark - Måløv

Are you committed to support a GMP production in Novo Nordisk? Right now, we are looking for a production chemist with a high quality mindset and GMP experience to join us in the HRT bulk production, a part of Biopharm Tablets & Finished Products.

About the department
The job is located in Biopharm T&FP HRT Bulk production, which is a tablet production producing HRT (Hormone Replacement Therapy) products including the processes; granulation, compression and coating. The department consists of 50 employees and is based in Måløv, Denmark and consists of three teams; Production, Tech Support and Process Support. The Process Support Team consists of 10 dedicated supporters.

The job
The primary responsibilities of this position will be to support the operators in the daily production and secure that we live the requirements of our quality management system and that we work systematically according to the LEAN principles implemented in the department. Furthermore, you will handle deviations from standard procedures, implement corrective actions, handle change requests, write protocols, reports and various documentations related to the HRT bulk production. You will also be a part of the team releasing the bulk batches. In this job, you will be in close contact with professional colleagues both in the department as well as in QA and QC department, Product Support and our Technical Team.

Our department is highly motivated and this position offers you a unique opportunity to strengthen your experience in a GMP production environment, realise personal as well as department goals and see the benefits of your work. You will experience an enthusiastic working climate where we take a personal responsibility for quality, delivery and each other.

Qualifications
You hold an academic degree (Cand. Pharm, chemical engineer or the equivalent). You have experience from pharmaceutical and knows how to perform in a GMP environment. Preferable you have knowledge of the LEAN principles. On a personal level you have a positive can-do attitude, you are engaged, systematic and take responsibility to ensure deadlines are met. You enjoy working with major challenges and can maintain an overview in a busy work day while complying with the requirements for manufacturing of drug products. You are fluent in both written and spoken Danish and English.

At Novo Nordisk, your skills, dedication and ambition help us change lives for the better. In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development.

Contact
For further information, please contact Charlotte Lex on +45 3075 2559.

Deadline
6 January 2014

QA Chemist (Gentofte, Denmark)

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QA Chemist

- Quality
- Denmark - Gentofte

Would you like to help securing release of Novo Nordisk A/S haemophilia portfolio, growth hormone portfolio and Glucagon filled product? Do you thrive when working in a team; handling multiple tasks of high complexity? Then you might be the person we are looking for in Biopharm QA Aseptic Production.

About the department
Biopharm QA AP is responsible for quality assurance of two existing aseptic filling plants in Gentofte, the building of a new filling plant in Kalundborg and all utility systems in the Gentofte production areas. Our key tasks are to review and approve all sorts of GMP documentation such as validation reports, change requests, non-conformities and batch documentation in order to be able to release filled product for packaging.

As QA Chemist in Biopharm QA AP you will join a group of 45 highly skilled and competent colleagues working in four teams lead by separate associate managers. By joining us you will get the chance of professional and personal development and you will get an excellent and unique overview of current authority expectations and demands in the pharmaceutical industry.

The Job
We have two vacant position situated in two different releasing teams for the filling plants in Gentofte. Both jobs include QA review of several types of documents related to release of pharmaceutical products. The documents comes from all types of processes in a filling plant, such as formulation, wash and sterilisation processes, filling, freeze-drying, and visual inspection. One of the vacant positions includes evening work with QA presence in the production area approximately two-three times pr. month.

Your main responsibility will be to quality assure the filling plants and thereby contribute to assure product quality and compliance with the current GMP rules and guidelines. On top of that QA is a major player at internal audits and external authority inspections, where you are expected to participate.

When started you will undergo an individual training program, where you can expect to be given more responsibility gradually.

Qualifications
You hold an academic degree that qualify you as QP (Qualified Person) according to the Danish Medical Agency. Preferable your academic background is topped with experience either from the pharmaceutical industry. However we would also like to hear from talented newly academic graduates.

You must thrive in a role where you are required to take leadership in order to achieve the shared targets in cooperation with your stakeholders. You have a strong quality mind-set, meet your deadlines, and know how to prioritise between different tasks in a dynamic environment. You are a dedicated team player who inspires trust amongst colleagues and partners. Your language skills cover proficiency in both Danish and English.

At Novo Nordisk, your skills, dedication and ambition help us change lives for the better. In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development.

Your application is welcome in Danish or English.

Contact
For further information, please contact QA Director Rikke Wissing Jensen at +45 3075 1566.

Deadline
2 January 2014

Toxicologist position for Product Supply and Device support (Måløv, Denmark)

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Toxicologist position for Product Supply and Device support

- Research & Development
- Denmark - Måløv

A toxicologist position (Senior Scientist/Principal Scientist) is open for employment in the Department of Toxicology and Safety Pharmacology Diabetes, in Måløv from February 1st, 2014 or as soon as possible thereafter.

About the department
Apart from performing non-clinical studies supporting the safety assessment of drug candidates, the department is responsible for assessment of leachables from materials used in primary packaging, medical devices and manufacture process aids. Furthermore, we assist Product Supply with toxicological evaluations relevant for GMP processes. Our department is characterized by an open, innovative and ambitious atmosphere with good opportunities for further development of the employees.

The Job
You will join our toxicology group and be responsible for toxicological assessments of non-active chemicals. You will be searching for toxicity data in the scientific literature and requesting relevant in silico and in vitro studies from external contract partners. Your role will be to support your colleagues in non-clinical development, medical device development and product supply in writing toxicological assessments of excipients, impurities and leachables. You will be responsible for planning and reporting biological risk management activities of our exciting portfolio of medical device projects for submission to regulatory authorities in accordance with international standards and guidelines. Occasionally, you will work in international expert groups and represent Novo Nordisk at scientific conferences.

Qualifications
You have a degree in life- or pharmaceutical sciences combined with a good understanding of physiology and pathology. You have a professional background in toxicological risk assessment preferably with several years´ experience in medical devices, food packaging and/or industrial chemicals. We expect you to be familiar with current regulatory guidelines in the area and with searching for and interpretation of data from toxicological studies published in international scientific journals. Ideally you have a solid understanding of organic chemistry and understand basic principles of the biotechnological manufacture processes and drug development. We will take care of any necessary additional training, coaching and education. We expect that you are clear in your communication, possess excellent written and spoken English skills and focus on providing high-quality, timely results in close collaboration with your internal and external stakeholders.

At Novo Nordisk, we create value by putting patients first. Every ten seconds two people are diagnosed with diabetes, and close to 366 million people worldwide need us. Working here is not just a way to make a living, but a way to make a difference.

Contact
For further information, please contact Ingrid Brück Bøgh at +45 3075 4515.

Deadline
16 December 2013

Tekniker til administrativt arbejde vikar 12 mdr (Gentofte, Danmark)

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Tekniker til administrativt arbejde vikar 12 mdr

- Forskning og Udvikling
- Danmark - Gentofte

Vil du bidrage til en hurtig og effektiv produktion og frigivelse af lægemidler til kliniske studier? CS Aseptic Pilot Plant er fuldt booket af produktioner, og søger derfor snarest en engageret laborant til at sikre vi kan følge med (vikar 12 mdr).

Om afdelingen
Aseptisk Pilot Plant er en mindre produktionsenhed i CMC clinical supplies med cirka 65 ansatte i Måløv. Vi befinder os i grænsefladen mellem udvikling og produktion og har bred kontakt til mange funktioner i virksomheden. Vores primære opgave er at producere aseptisk fremstillede færdigvarer til brug i prækliniske og kliniske studier i forbindelse med virksomhedens udviklingsprojekter. Vi er ca. 15 personer i teamet (halvt teknikkere og halvt kemikere), der alle bidrager med proaktiv tankegang og selvstændigt planlægning af arbejdet. Vi tager gerne alle ansvar, og har stor respekt for hinandens kompetencer.

Jobbet
Du vil få ansvaret for flere af de skrivebordsopgaver, der er en del af produktion af lægemidler under aseptiske betingelser. Det vil blandt andet være gennemgang af vores batch dokumentation og koordinering af aktiviteter i forbindelse hermed. Derudover vil du få ansvaret for arkivering og også indgå i registrering af vores råvare og DP i vores IT systermer. Din rolle vil kræve samarbejde på tværs i hele afdelingen.

Kvalifikationer
Vi forventer, at du er uddannet laborant. Du har gerne erfaring med præparation af lægemidler under klassificerede forhold, og den tilhørende dokumentation. Du har viden om cGMP, god til detaljer og både lyst og evne til skriftligt arbejde. Du kommunikerer åbent og konstruktivt, er initiativrig, fleksibel og ansvarsbevidst. Du skal kunne bevare overblikket over mange opgaver på én gang i et til tider meget hektisk miljø.

I Novo Nordisk er det dine evner, dit engagement og dine ambitioner, der hjælper os med at forbedre mange menneskers liv. Til gengæld tilbyder vi dig muligheden for at arbejde sammen med usædvanligt talentfulde kolleger, og vi tilbyder dig en lang række muligheder for professionel og personlig udvikling.

Kontakt
Vil du vide mere om stillingen, så kontakt teamleder Lene Kragelund på tlf. 3079 3601.

Ansøgningsfrist
10 January 2014

Process Responsible - influence and impact (Hillerød, Denmark)

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Process Responsible - influence and impact

- Production
- Denmark - Hillerød

Are you a skilled communicator with high-level knowledge within technical processes and GMP? If yes, this could be a grand opportunity for you to pursue your ambitious goals. Join our Support Team on our exciting journey towards enabling short- and long-term success for our production.

About the department
The department consists of approximately 80 employees who daily ensure the assembly of millions of FlexPen® for diabetics around the world. The department is comprised of 2 production teams, 1 technical support team and 1 quality support team. The environment is characterized by fast pace and daily re-prioritizations to ensure timely delivery of quality products to many different customers. There is an open and honest atmosphere in which we aim to utilize and develop your competencies and skills.

The Job
As Process Responsible your overall objective is to ensure high efficiency, stability and quality in our current and future production/processes. You will be responsible for improving and implementing technical processes according to GMP in close dialogue with colleagues at all organisational levels from operators to vice presidents. If deviations occur you will function as sparring partner and expert within your field of knowledge. On site you will be responsible for maintenance for structure, facilitate meetings and in total ensure we make continuous improvements in our processes. You will also assist the team leaders in developing the right competences to meet our goals. Another vital task is to function as sparring partner in developing and aligning processes across production sites globally; therefore you can expect an average of 20 travel days per year.

Qualifications
Your background is a degree in chemical engineering, pharmacy, veterinary science or similar backed by a minimum of 3 years’ experience within a highly regulated industry. Your career has provided you with high evel knowledge about GMP and proves your ability to transform expert knowledge into business performance. As a person, you have an eye for structure and you excel in communicating clearly and constructively, challenging ideas and making decisions while keeping everyone feeling included in the process. Just as important is your ability to establish good relations to a wide number of people across professional and geographical borders. Finally, you must have proficiency in Danish and English, as you will be working in an international environment.

At Novo Nordisk, you will be part of a company respected equally for its financial results and its business ethics. Across geographical, cultural and professional communities we develop and deliver innovative medicines for the benefit of patients.

Contact
For further information, please contact Christian Rank at +45 3075 4929 or Jacob Dam Sørensen at +45 3075 2354.

Deadline
22 December 2013

Proces tekniker (Hillerød, Danmark)

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Proces tekniker

- Produktion
- Danmark - Hillerød

Vil du arbejde med verdensklasse produktion og være med til at sætte standarden for plastsprøjtestøbning i Danmark og resten af verden? Og er du klar til et markant ansvar med fokus på kvalitet, produktion og processer samt faglig og personlig udvikling? Så er du sikkert vores nye kollega i processupporter teamet, der består af ca. 40 højt engagerede medarbejdere. Vi skaber fortsat stor vækst og gode resultater og har derfor brug for fire teknikere med speciale indenfor plastsprøjtestøbningsprocesser og værktøjer.

Om afdelingen
I Moulding Support, som er en del af DMS Proces Support, yder vi support til vores plastsprøjtestøbeproduktion af plastkomponenter i hele verden. Dine nye kollegaer i Moulding Support er en gruppe dedikerede og yderst kompetente mennesker, og du vil få rig mulighed for sparring og udvikling af egne kompetencer. Afdelingen består af ca. 25 procesingeniører og 15 procesteknikere.

Du bliver del af en afdeling, hvor LEAN står højt på dagsordenen. Vi stræber efter ambitiøse mål og optimerer løbende på vores arbejdsgange og processer. Vi har samtidig stort fokus på trivsel og udvikling af medarbejdere.

Vi har nu brug for dit engagement og dine kompetencer i vores afdeling, for at vedligeholde og optimere vores produktions linjer til at være blandt de allerbedste i verden.

Jobbet
Vi er en afdeling i rivende udvikling, og foruden ekspert teknisk support på den kørende produktion, vil dine primære arbejdsopgaver blive systematisk problemløsning og fejretning på udstyr som bryder ned, indkøring af nye forme samt deltagelse ved formgodkendelsesaktiviteter hos værktøjsmagere i både DK og udlandet.

Du vil skulle forvente et sted mellem 35-45 rejsedage om året i denne stilling.

Stillingen er kategoriseret til lønklasse F5.

Kvalifikationer
Vi forestiller os, at du har en faglig uddannelse som plasttekniker, værktøjsmager, maskinarbejder, eller anden relevant baggrund. Vi ser gerne du har flere års indgående kendskab til plastsprøjtestøbning og optimering af forme og ekstraudstyr.

Det er nødvendigt, at du kan begå dig problemfrit på engelsk og at du er vant til at anvende IT, da IT danner grundlag for en stor del af vores processer, og arbejdsgange. Det er desuden vigtigt, at du har stærk kvalitetsforståelse, da vi arbejder indenfor ISO/GMP. Et godt kendskab til LEAN og systematisk problemløsning vil være en fordel.

Som person har du gode samarbejdsevner og et opsøgende service mind-set. Du er fleksibel med stor ansvarsfølelse, og parat til en hverdag med variation i opgaverne. Du er en holdspiller og en god kollega, der altid er parat til at give en hånd med.

Endvidere lægger vi vægt på, at du har en god ordenssans samt et godt humør.

I Novo Nordisk baseres beslutninger og handlinger på deres indflydelse på samfundet, miljøet og muligheden for at skabe økonomisk overskud. Det skaber tilsammen en ansvarlig kultur med et sundt og engageret arbejdsmiljø.

Kontakt
Vil du vide mere om stillingen, så kontakt Paw Holmgaard Krogh på telefon +45 3075 4269.

Ansøgningsfrist
17 December 2013

Værktøjs tekniker (Hillerød, Danmark)

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Værktøjs tekniker

- Produktion
- Danmark - Hillerød

Introduktion

Vil du arbejde med værktøjer i verdensklasse og være med til at sætte standarden for plastsprøjtestøbning i Danmark og resten af verden? Og er du klar til et markant ansvar med fokus på kvalitet, produktion og processer samt faglig og personlig udvikling? Så er du sikkert vores nye kollega i processupporter teamet, der består af ca. 40 højt engagerede medarbejdere. Vi skaber fortsat stor vækst og gode resultater og har derfor brug for en dygtig værktøjsmager, til at servicere vores støbeforme.

Om afdelingen
I Moulding Support, som er en del af DMS Proces Support, yder vi support til vores plastsprøjtestøbe produktion af plastkomponenter i hele verden. Dine nye kollegaer i Moulding Support er en gruppe dedikerede og yderst kompetente mennesker, og du vil få rig mulighed for sparring og udvikling af egne kompetencer. Afdelingen består af ca. 25 procesingeniører og 15 procesteknikere.

Du bliver del af en afdeling, hvor LEAN står højt på dagsordenen. Vi stræber efter ambitiøse mål og optimerer løbende på vores arbejdsgange og processer. Vi har samtidig stort fokus på trivsel og udvikling af medarbejdere.

Vi har nu brug for dit engagement og dine kompetencer i vores afdeling, for at vedligeholde vores produktionsforme så vi kan fortsætte med at være blandt de allerbedste i verden indenfor produktion af plastkomponenter.

Jobbet
Vi er en afdeling i rivende udvikling, og foruden ekspert teknisk support på den kørende produktion, vil dine primære arbejdsopgaver blive større årlige services på forme i den interne produktion i Hillerød, systematisk problemløsning og fejlretning på udstyr der bryder ned, samt ad-hoc service på vores støbeforme i resten af verden.

Du vil skulle forvente et sted mellem 10-20 rejsedage om året i denne stilling.

Stillingen er kategoriseret til lønklasse F5.

Kvalifikationer
Vi forestiller os, at du har en faglig uddannelse som værktøjsmager eller lign. og vi ser gerne du har flere års praktisk erfaring.

Det er nødvendigt, at du kan begå dig problemfrit på engelsk og at du er vant til at anvende IT, da IT danner grundlag for en stor del af vores processer, og arbejdsgange. Det er desuden vigtigt, at du har stærk kvalitetsforståelse, da vi arbejder indenfor ISO/GMP. Et godt kendskab til LEAN og systematisk problemløsning vil være en fordel.

Som person har du gode samarbejdsevner og et opsøgende service mind-set. Du er fleksibel med stor ansvarsfølelse, og parat til en hverdag med variation i opgaverne. Du er en holdspiller og en god kollega, der altid er parat til at give en hånd med.

Endvidere lægger vi vægt på, at du har en god ordenssans samt et godt humør.

I Novo Nordisk baseres beslutninger og handlinger på deres indflydelse på samfundet, miljøet og muligheden for at skabe økonomisk overskud. Det skaber tilsammen en ansvarlig kultur med et sundt og engageret arbejdsmiljø.

Kontakt
Vil du vide mere om stillingen, så kontakt Paw Holmgaard Krogh på telefon +45 3075 4269.

Ansøgningsfrist
17 December 2013

Håndværkere (Gentofte, Danmark)

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Håndværkere

- Produktion
- Danmark - Gentofte

Har du lyst til at arbejde i en afdeling, hvor der de kommende år skal foretages store investeringer for at levere væksthormon til et stigende marked og vil du være med til at holde vores livsvigtige produktionsudstyr i topform? Så har du chancen for at blive en del af et udstyrsteam med et højt niveau af faglighed og sparring, en åben og ærlig dialog med gensidig respekt og en god portion humor.

Om afdelingen
Biopharm API hGH producer væksthormon (HGH) API og omfatter fermentering, grov- og finrensning og vi har ansvaret for produktet, indtil det frigives til vores fyldefabrik. Vi er i dag 78 medarbejdere i afdelingen.

Teamet hedder ”018 Support Automatik og udstyr” og består i dag af 17 medarbejdere, bl.a. ingeniører, teknikere og håndværkere. Vi yder teknisk sparring, systematisk fejlsøgning og løbende vedligehold på afdelingens udstyr.

Jobbet
Sammen med udstyrsteamets øvrige 4 faste håndværkere bliver du ansvarlig for udførelse af kalibrering af udstyr, drift af utility samt afhjælpende og forebyggende vedligehold af procesanlægget. I samarbejde med produktionen, processupporten og dine kolleger skal du planlægge og udføre vedligehold og kalibrering samt udbedring af fejl på afdelingens udstyr. Til styring af vedligehold og kalibrering anvender vi SAP PM og QM, og i forbindelse med fejl på udstyret anvender vi systematisk problemløsning i form af 3C og A3. Stillingen er kategoriseret som en kategori F4 stilling.

Kvalifikationer
Du er uddannet som elektriker, automatikmekaniker eller lignende og har erfaring med vedligehold af utility- eller procesudstyr. Har du også kendskab til kalibrering, er det en fordel. Vi forestiller os, at du har erfaring med lignende anlæg og er vant til at arbejde efter GMP/ISO-regler. Det er klart en fordel, hvis du kender til SAP PM og QM og er fortrolig med at arbejde med systematisk problemløsning. Du får en omskiftelig hverdag, hvor der løbende sker omprioriteringer, og det er derfor en forudsætning, at du er fleksibel og omstillingsparat. Samtidig udviser vi en stor grad af ansvar og selvstændighed både i forhold til løsninger og planlægning. Du skal derfor være god til at arbejde både selvstændigt og i team.

Vi tilbyder dig muligheden for at arbejde sammen med talentfulde kolleger, og vi tilbyder dig en lang række muligheder for professionel og personlig udvikling.

I Novo Nordisk er det dine evner, dit engagement og dine ambitioner, der hjælper os med at forbedre mange menneskers liv. Til gengæld tilbyder vi dig muligheden for at arbejde sammen med usædvanligt talentfulde kolleger, og vi tilbyder dig en lang række muligheder for professionel og personlig udvikling.

Kontakt
Vil du vide mere om stillingen så kontakt Lene Madsen (LMad) på +45 3075 8342.

Ansøgningsfrist
12 december 2013

Regulatory Professional (Søborg, Denmark)

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Regulatory Professional

- Regulatory Affairs
- Denmark - Søborg

Novo Nordisk Regulatory Affairs makes medicine available to patients all over the world by ensuring rapid regulatory approvals in all our markets. Regulatory Affairs is a fast-changing field, and the dedicated employees in our unit need both keen negotiating skills and scientific insight into the regulatory challenges.

About the department
We are a team of engaged specialists working with development of oral formulations of insulin and GLP-1 analogues.

We are currently looking for a Regulatory Professional with science background combined with regulatory experience to support our activities related to clinical trial submissions and approvals and interactions with health authorities.

The job
In Regulatory Affairs, you’ll work in a fast-paced environment where no two days are alike. Tight deadlines, cross-departmental collaboration, project management and the challenges of international communication will be part of your busy workday. You’ll be expected to make an impact, to ask questions and challenge the status quo if that’s what it takes.

As a Regulatory Professional you will be required to drive, coordinate and actively follow-up on several tasks with challenging and often overlapping timelines.

You will be a member of cross functional project teams including study groups and submission teams, and as such, interact with variety of stakeholders from different departments in Novo Nordisk. You will participate in review of clinical trial protocols and reports as well as development of regulatory documentation for submission to health authorities, including briefing packages for meetings with health authorities, clinical trial applications, safety reports and finally regulatory file for marketing authorization. You will be expected to provide regulatory input, be proactive, challenge the discussions and contribute to project team decisions.

Qualifications
We expect you to have a university degree in science (Ph.D degree will be an advantage) and 3-5 years of relevant experience from the pharma industry.

As a person, you thrive in busy environment; bring can-do spirit and a healthy sense of humour to your work – even when the pressure is on. You are flexible and change-oriented person who in challenging situations can see opportunities rather than limitations.

You’re a strong team player, but you are also able to work independently and find new solutions to the challenges you meet. You’re also a skilled communicator who is comfortable speaking and writing in English.

At Novo Nordisk, we strive for excellence. As a world leader in diabetes care and a major player in haemostasis management, growth hormone therapy and hormone replacement therapy, we offer our employees opportunities for continuous growth.

Contact
For further information, please contact Vibeke Hatorp on +45 3075 5697.

Deadline
20 December 2013.

Test Coordinator (Hillerød, Denmark)

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Test Coordinator

- Quality
- Denmark - Hillerød

Do you have solid planning and organising skills? Are you looking for a job where you play a key role ensuring the quality of Devices before they reach the hands of millions of people living with diabetes worldwide? Then we encourage you to keep reading as we are looking for a new Test Coordinator.

About the department
You will join a team providing verification tests of devices to support device development projects in Device Manufacturing Development. You will have 12 new colleagues, including Laboratory Technicians, Technicians and Engineers, who are dedicated to deliver test documentation that, ensure the authorities’ approvals of assembled Devices.

The Job
Your goal will be to carefully coordinate the work of your team ensuring that we deliver verification test reports of high standard on time. You will coordinate the testing of products before they are launched to market as well as marketed products subjected to changes or problem solving. As a key figure managing the contacts for your team, you can foresee close collaboration with colleagues in R&D, Product Maintenance and Regulatory Affairs. You will also attend to board meetings to secure participation from key stakeholders, as well as you plan workshops and communicate the role of the department to other stakeholders. At all times, you make sure to follow up on planning issues and challenges, just as you ensure smooth communication between your team, customers and stakeholders. You can look forward to a challenging position where you will gain vast insight into our testing environment and work with colleagues in Denmark and other parts of the global organisation.

Qualifications
Your background covers a degree in Engineering or similar and solid experience managing or coordinating projects. If you are familiar with different testing standards or equipment or have acquired experience from a GMP regulated environment it will be an advantage. On a personal level, you demonstrate sound interpersonal and communication skills. Colleagues know you as a person with a proactive mindset who enjoys building relations and collaborating across interdisciplinary boundaries. It goes without saying that you must have strong planning skills and a structured approach in order to keep focus on many tasks simultaneously. It shows that you have drive and that you get your energy from working in a high-paced environment with many deadlines. At the same time, you know how to support and motivate others to make them deliver on their targets. Lastly, you have proficiency in written and spoken English.

At Novo Nordisk, your skills, dedication and ambition help us change lives for the better. In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development.

Contact
For further information, please contact Lars Aagaard +45 3079 2095.

Deadline
8 December 2013

QA Director (Kalundborg, Denmark)

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QA Director

Learn more about the largest site in Novo Nordisk�s global production network using this link www.novonordisk.com/kalundborg-careers

- Management
- Denmark - Kalundborg

Would you like to lead and be part of a professional and highly engaged Quality Management Team and be responsible for assuring the quality from A to Z in our production?

We are expanding our activities at our production sites in Kalundborg and are looking for a talented and ambitious director to lead the quality assurance management team, setting the standard going forward.

About the department
The QA unit is responsible for assuring quality and compliance of all production of insulin products in Denmark. This includes facilities, aseptic filling, inspection, assembly and packaging of insulin products.

The department is responsible for assuring quality and compliance for all production operation activities at Kalundborg which include aseptic production of insulin vials, assembly and packaging of insulin finished products.

Our key objectives are to assure product quality and regulatory compliance by defining quality requirements, perform quality oversight and by approving quality documents such as procedures, change request and batch- & validation documents. We participate in all production related activities to monitor the processes and to secure a strong stakeholder relation.

The job
As QA Director in Kalundborg you will join a group of 13 engaged managers and more than 100 highly skilled and competent colleagues; all dedicated to quality mind-set and continuous improvement.

You will be reporting to the Quality Vice President and have three Associate Managers with app. 30 employees. The primary responsibility will be to assure the quality of all aspects of insulin finished product production in Kalundborg incl. aseptic operation. It is expected that you actively work with development of individual and show the way going forward by creating an engaging working environment throughout the organisation. You will support the teams in decision making and take active part in internal audit and inspection from the authorities. As Quality Director you will be involved in cross functional projects and alignment activities across DFP Sites.

The job offers you an opportunity to develop both professionally and personally in a changing and inspiring environment. In order to set the bar, it is a prerequisite that you are able to handle high complexity and ensure business deliverable without compromising compliance or quality.

Qualifications<
You hold a master degree and have 6-8 years of leadership experience in the pharmaceutical industry within quality or production. You have a deep knowledge of quality assurance, master stakeholder management and collaboration and are excellent in communicating your expectations. In addition, it is expected that you have experience in ensuring compliance with standards and strive for high level of product quality through continuous improvement. You have integrity and an excellent quality mind-set. A high level of personnel decision making and authority within the team’s field of responsibility is needed. Your language skills cover proficiency in both Danish and English.

At Novo Nordisk, we create value by putting patients first. Every ten seconds two people are diagnosed with diabetes, and close to 366 million people worldwide need us. Working here is not just a way to make a living, but a way to make a difference.”

Your application and CV is welcome in Danish or English.

Contact
For further information, please contact Morten Juul Sørensen at +45 3075 1652.

Deadline
31 December 2013.

Validation Process Engineer (Hillerød, Denmark)

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Validation Process Engineer

- Production
- Denmark - Hillerød

Device manufacturing & Sourcing (DMS) seeks a talented engineer with experience within the field validation and qualification.

If you have a great quality mindset and always strive for improvements and possess in-depth knowledge within validation and qualification then go for this job.

About the department
DMS is focused on introduction of moulded components for medical devices, maturation of the production setup to excellence and sourcing the components to sister sites abroad. The area is at a high development pace and we need an experienced engineer in Mould Pipeline & Validation (MPV), which is a team responsible for ordering and approval of injection moulds for plastic parts for prefilled devices produced internally in Hillerød DK and on various production sites worldwide.

The Job
You will be responsible for various validation activities such as execution, writing and reviewing validation plans, protocols, and reports associated with Installation Qualification, (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) to ensure quality and compliance. You will also be responsible for continually improving the validation documentation and related standard operating procedures as well as you will be involved in problem solving when specifications or requirements are not met.

You will have a very high degree of influence and planning of your own job and daily tasks within the validation activities as well as working with the highest quality and complex equipment within injection moulding and tooling.

We can offer you a workplace with an international atmosphere, surrounded by talented and dedicated colleagues with whom you can exchange experiences.

Qualifications
You have a background as validation engineer or similar experience.

You have some experience with validation and/or qualification of production tools within the pharmaceutical industry or other regulated industry. Furthermore, you have a good understanding of GxP and a high quality mind-set. You possess good interpersonal skills, are process oriented and have the ability to communicate simple and uncomplicated. It is also important you support the rest of us in creating a positive spirit and a good department. Communication in English in speech and writing is a necessity, since you will cooperate with international suppliers and customers. The position also includes travel.

At Novo Nordisk we use our skills, dedication and ambition to help people with diabetes and change their lives. By working with us, you will have the opportunity to do the same in a global business environment.

Contact
For further information, please contact Laura Sørensen at +45 3075 0463.

Deadline
1 January 2014

QA Associate Manager (Gentofte, Denmark)

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QA Associate Manager

- Quality
- Denmark - Gentofte

Do you want responsibility for developing people and optimizing processes in a core part of Novo Nordisk’s QA organization? You will be leading a highly competent QA team of 8 employees responsible for the quality assurance of Biopharm Manufacturing Development. Since the team is newly established, we are now looking for a new colleague to lead the team.

About the department
“Biopharm QA QC & Support” consists of two teams, one responsible for quality assurance of QC analyses and the other responsible for quality assurance of development activities. Our key tasks are to review and approve GMP documentation such as validation reports, change requests and non-conformities in order to be able to insure delivery of high quality products in compliance.

The Job
As Associate Manager in Biopharm QA Support team you will be the leader of 8 highly skilled and motivated QA professionals, forming a new team since 1 November 2013. The team provides quality assurance for the manufacturing development activities in Biopharm and as associate manager you will be involved both as QA person handling cases and as a representative of the department manager. You set a good example and lead the way to ensure that your employees obtain the right behaviour and achieve the targets all to the benefit of our patients. You act as a competent sparring partner to your team you coach and empower your employees to deliver excellent results. You collaborate with the Manufacturing Development departments in a professional and amicable way and collaborate to overcome disagreements while never compromising on quality mindset and compliance.

Qualifications
You have a solid working experience from a QA organization which ideally is from a similar role in a pharmaceutical company and your experience is paired with a relevant Master of Science degree. You set and communicate a clear direction for your team. You display a high level of personal engagement, drive, persistence and integrity. Precise communication is essential and you must be capable of taking part in constructive cooperation concerning the various tasks and have the kind of impact that means that you can stand firm in favour of product and user safety, as well as compliance. Your language skills cover proficiency in both Danish and English.

Feel free to submit your job application in either English or Danish, whichever you prefer.

At Novo Nordisk, we strive for excellence. As a world leader in diabetes care and a major player in haemostasis management, growth hormone therapy and hormone replacement therapy, we offer our employees opportunities for continuous growth.

Contact
For further information, please contact Ulla Thinggaard at +45 3075 2104.

Deadline
03 January 2014

Senior Business Analyst (Bagsværd, Denmark)

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Senior Business Analyst

- Finance
- Denmark - Bagsværd

Novo Nordisk is one of the world’s most successful pharmaceutical companies with a great growth potential. Do you want to be part of ensuring that this growth happens in full financial control?

About the department
Corporate Financial Planning is part of Corporate Finance (300 employees) and is responsible for the financial management of Novo Nordisk with a close link to the business worldwide. Our aim is to be the best finance operation in the global pharma industry. You will be part of a young and dynamic finance team consisting of 40 dedicated employees split into 6 smaller teams. We have close cooperation with the business units and our aim is to act as true business partners based on strong financial competencies combined with a good understanding of the business in which we operate.

The Job
You will be the finance partner for one or more of our business units, including supporting the unit(s) on various financial matters. Our key process related responsibilities are to facilitate the budget process in the areas and provide monthly follow up to senior management. You might also be invited to attend the management meetings as their financial advisor. Furthermore, in order to optimize the financial development within your area of responsibility, you will be involved in various projects and ad hoc analysis.

Qualifications
The person we are looking for has at least two years of relevant experience and has completed a relevant master's degree (i.e. in finance or economics) with excellent results. You have strong analytical skills, are computer literate and ready to invest time and effort in your development and future career. Furthermore, it is important that you have good communication skills, including being fluent in written and spoken English as well as being able to communicate with people at all levels of the organisation. The atmosphere in Corporate Financial Planning is informal and humorous. If you can hold on to your good sense of humour at all times, you are the kind of person we are looking for.

We invest a lot in both professional and personal development and have an individualised development plan for each employee. Through on-the-job training, projects and courses you will experience a continued steep learning curve, thus enabling a number of future career opportunities in the global Novo Nordisk organisation.

At Novo Nordisk, we strive for excellence. As a world leader in diabetes care and a major player in haemostasis management, growth hormone therapy and hormone replacement therapy, we offer our employees opportunities for continuous growth.

Contact
For further information, please contact Tine Andreasen, director of Staffs Finance, on +45 3079 9023.

Deadline
22 December 2013

QA Professional - CMC Analysis QA (Måløv, Denmark)

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QA Professional - CMC Analysis QA

- Research & Development
- Denmark - Måløv

Do you want to unfold your profound QA knowledge and your huge appetite for creating results in a pharmaceutical development environment? If so, please apply for the position as QA Professional in a job that includes many different clinical stages of the product development.

About the department
In Chemistry, Manufacturing & Control (CMC) Analysis QA we ensure that all analysis activities for all Novo Nordisk development projects live up to cGMP requirements.

We are 11 highly dedicated colleagues in the department located in R&D in Måløv. Our mission is to assure that all our analysis development processes and development laboratories meet the internal and external requirements.

The Job
In close cooperation with your colleagues in QA, you act as a consultant for our analytical development departments. You contribute to find solutions for ad hoc questions and challenges within compliance of the analytical development activities. You will approve qualification and validation documentation from analytical departments in the process of release of Active Pharmaceutical Ingredients (API) and Drug Product (DP) for clinical trials. You have a risk based approach to the development process and product, and you contribute to find the right balance between patient safety, compliance to requirements and effective business conduct.

We operate in a LEAN-dominated environment, and you will have the opportunity to contribute with ideas for improvements and drive the subsequent implementation as well. Working within QA will definitely challenge your professional and individual skills.

CMC Supply’s continuing high level of audit and inspection readiness is on top on your agenda.

In CMC Supply QA we work with QA oversight where you proactive together with your colleagues will identify areas where our stakeholders’ compliance can be strengthened.

Qualifications
You hold a Master’s degree in Pharmacy or possess equivalent qualifications besides a strong quality mindset. You have at least 3 years of experience. The ideal candidate has thorough knowledge within following areas: GMP, analysis validation, analysis equipment qualification, regulatory requirements to analysis for investigational medicinal products for use in clinical trials and LEAN skills. Preferably you have a solid experience within IT equipment system regulatory requirements. You are fluent written and spoken English on a professional level.

You are good at building relations to colleagues and stakeholders across the organisation. You possess power of determination and are not afraid to handle complex tasks through a constructive dialog and teamwork with your colleagues as partners. In addition, you are able to deliver in due time to meet our customers’ expectations. You are a team player and a skilled communicator, and you thrive on unfolding your high level of energy and knowledge in an international, dynamic environment. You are able to adapt but also challenge our way of working so that we constantly improve our methods and processes.

At Novo Nordisk, your skills, dedication and ambition help us change lives for the better. In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development.

Contact
For further information, please contact Pernille Uldall Bolvig at +45 3079 7548.

Deadline
20 December 2013
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