QA Engineer
- Quality
- Denmark - Hillerød
Would you like to work in an international environment and be responsible for the quality assurance of the components for the future prefilled insulin pen? Are you ready to take high impact decisions regarding right level of quality to ensure patient safety? Then you might be the person we are looking for.
About the department
Due to a production ramp-up, we are looking for a dedicated person with an academic background who will be part of the Manufacturing QA team of 8 QA engineers. The Manufacturing QA team is responsible for the quality assurance of components delivered for our high volume production of medical devices worldwide.
The job
You will be responsible for the quality assurance and daily release as well as status assignment of components e.g. FlexPen® and FlexTouch® for further production. In particular, you approve the status and release the components for all global warehouses produced both internally in DMS and by external suppliers located in Europe, USA and Brazil. As part of the release process you will also perform a thorough review of the batch documentation as well as enter and maintain the data in our IT-systems PRISM/SAP/LMES. With support from your colleagues, you will ensure that components are released in compliance with Novo Nordisk regulations, legal requirements, GMP, and ISO standards. To achieve that, you will be in daily contact with suppliers, customers, and internal colleagues at DMS such as Process Support, Logistics & QC, Mould-, and Pre-Assembly Production.
Quality Mind-set and winning culture are incorporated concepts of our daily work. We offer you a position in an international company with many exiting challenges giving you the possibility for individual development We prioritise a good work life balance. We are located in Hillerød in nice surroundings and new facilities approx. 30 km. north of Copenhagen.
Qualifications
First and foremost you have an excellent quality mind-set, good communicational skills and you can place the importance of compliance on the agenda in a positive and constructive way.
You hold an academic degree. Preferably your academic background is topped with
3-5 years of experience with quality assurance within the pharmaceutical industry or from a Production company. It is an advantage if you have experience with ISO13485, GMP, and Lean or process insight in injection moulding and assembly production
Your language skills cover proficiency in both Danish and English,
As a person, you are known for a high commitment to finding constructive solutions as well as taking responsibility for your assignments.
You enjoy the mixture of routine tasks and more challenging tasks, and you are flexible to changes in workflow. Additionally, you work independently and you make decisions regarding quality tasks ensuring the right balance between quality demands, authority demands and business needs. At the same time, you perform well in a team-oriented environment.
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 call Lotte Nielsen + 45 3079 4276.
Deadline
27 January 2014.
- Quality
- Denmark - Hillerød
Would you like to work in an international environment and be responsible for the quality assurance of the components for the future prefilled insulin pen? Are you ready to take high impact decisions regarding right level of quality to ensure patient safety? Then you might be the person we are looking for.
About the department
Due to a production ramp-up, we are looking for a dedicated person with an academic background who will be part of the Manufacturing QA team of 8 QA engineers. The Manufacturing QA team is responsible for the quality assurance of components delivered for our high volume production of medical devices worldwide.
The job
You will be responsible for the quality assurance and daily release as well as status assignment of components e.g. FlexPen® and FlexTouch® for further production. In particular, you approve the status and release the components for all global warehouses produced both internally in DMS and by external suppliers located in Europe, USA and Brazil. As part of the release process you will also perform a thorough review of the batch documentation as well as enter and maintain the data in our IT-systems PRISM/SAP/LMES. With support from your colleagues, you will ensure that components are released in compliance with Novo Nordisk regulations, legal requirements, GMP, and ISO standards. To achieve that, you will be in daily contact with suppliers, customers, and internal colleagues at DMS such as Process Support, Logistics & QC, Mould-, and Pre-Assembly Production.
Quality Mind-set and winning culture are incorporated concepts of our daily work. We offer you a position in an international company with many exiting challenges giving you the possibility for individual development We prioritise a good work life balance. We are located in Hillerød in nice surroundings and new facilities approx. 30 km. north of Copenhagen.
Qualifications
First and foremost you have an excellent quality mind-set, good communicational skills and you can place the importance of compliance on the agenda in a positive and constructive way.
You hold an academic degree. Preferably your academic background is topped with
3-5 years of experience with quality assurance within the pharmaceutical industry or from a Production company. It is an advantage if you have experience with ISO13485, GMP, and Lean or process insight in injection moulding and assembly production
Your language skills cover proficiency in both Danish and English,
As a person, you are known for a high commitment to finding constructive solutions as well as taking responsibility for your assignments.
You enjoy the mixture of routine tasks and more challenging tasks, and you are flexible to changes in workflow. Additionally, you work independently and you make decisions regarding quality tasks ensuring the right balance between quality demands, authority demands and business needs. At the same time, you perform well in a team-oriented environment.
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 call Lotte Nielsen + 45 3079 4276.
Deadline
27 January 2014.