QA Academic for qualification of Pilot Plants
- Quality
- Denmark - Gentofte
CMC API QA within R&D, Novo Nordisk A/S, Gentofte, is expanding and we’re seeking two QA Academic’s with drive and personality. Would you enjoy the high activity of the QA work in assuring the quality of facilities and equipment in CMC API Development? Do you want to unfold your profound QA knowledge and your huge appetite for creating results in a pharmaceutical development environment? Then you might be the QA Professional with the drive and performance we need.
About the department
CMC API QA has the responsibility of assuring that API (Active Pharmaceutical Ingredients) activities in development and support projects in Novo Nordisk A/S fullfill cGMP requirements.The department consists of 29 employees organised into three teams. You will be a part of the Downstream Team in CMC API QA. You will join a team of 10 highly dedicated colleagues. Our mission is to assure that all our pilot plants and development laboratories meet the internal and external requirements. The pilot plants and the development laboratories are located in Bagsværd, Gentofte, Måløv and Hillerød. During the week you will be moving between the different locations and the QA office. This way of working requires that you have the ability to be a team player on distance.
The job
With responsibility of one or several of our pilot plants CMC API Development’s continuing high level of audit and inspection readiness is on top on your agenda. You will be in charge of assuring quality of our production areas with regards to validation and qualification of equipment, environment and utilities. Document approval in connection with qualification, cleaning, maintenance and improvement of the quality system (SOP’s) and other documentation from the facility, will be included in your daily tasks. The responsibility of maintenance and improvement of the quality systems is also based on close cooperation between the pilot plants and QA. Great interpersonal skills and high spirits will therefore be a necessity. In cooperation with your colleagues in QA, you act as a consultant for our pilot plant and you will experience a lot of time spend on competent feedback with internal in QA colleagues and colleagues from the pilot plants. We operate in a LEAN orientated environment and you will have the opportunity to contribute with ideas and improvements and to drive the implementation of these. Working within QA your professional and individual skills will be challenged and you will find that your tasks will include many different clinical stages in the product development.
Qualifications
You hold a Master’s degree in Pharmacy, Chemical Eng. or possess equivalent qualifications besides a strong quality mindset. You have at least a few years of experience within QA or other related disciplines. The ideal candidate has thorough knowledge within one or more of following areas: GMP, validation, equipment qualification, regulatory requirements to validation/qualification in pilot plants for investigational medicinal products for use in clinical trials and LEAN skills. You are fluent written and spoken Danish and English on a professional level. With your good cooperation and communication skills you are able to organise and drive tasks. You take a pragmatic approach to problem solving and have strong interpersonal skills. You are detail-oriented with a strong quality mind set and are a team player, but also able to work independently. You thrive on working across departments in an international organisation. We look for an open minded person with an outgoing attitude, natural networking skills. And we would enjoy having a straightforward person with a good sense of humour in our department.
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 Peter Søtofte Elten at +45 3079 8453.
Deadline
23 November 2013.
- Quality
- Denmark - Gentofte
CMC API QA within R&D, Novo Nordisk A/S, Gentofte, is expanding and we’re seeking two QA Academic’s with drive and personality. Would you enjoy the high activity of the QA work in assuring the quality of facilities and equipment in CMC API Development? Do you want to unfold your profound QA knowledge and your huge appetite for creating results in a pharmaceutical development environment? Then you might be the QA Professional with the drive and performance we need.
About the department
CMC API QA has the responsibility of assuring that API (Active Pharmaceutical Ingredients) activities in development and support projects in Novo Nordisk A/S fullfill cGMP requirements.The department consists of 29 employees organised into three teams. You will be a part of the Downstream Team in CMC API QA. You will join a team of 10 highly dedicated colleagues. Our mission is to assure that all our pilot plants and development laboratories meet the internal and external requirements. The pilot plants and the development laboratories are located in Bagsværd, Gentofte, Måløv and Hillerød. During the week you will be moving between the different locations and the QA office. This way of working requires that you have the ability to be a team player on distance.
The job
With responsibility of one or several of our pilot plants CMC API Development’s continuing high level of audit and inspection readiness is on top on your agenda. You will be in charge of assuring quality of our production areas with regards to validation and qualification of equipment, environment and utilities. Document approval in connection with qualification, cleaning, maintenance and improvement of the quality system (SOP’s) and other documentation from the facility, will be included in your daily tasks. The responsibility of maintenance and improvement of the quality systems is also based on close cooperation between the pilot plants and QA. Great interpersonal skills and high spirits will therefore be a necessity. In cooperation with your colleagues in QA, you act as a consultant for our pilot plant and you will experience a lot of time spend on competent feedback with internal in QA colleagues and colleagues from the pilot plants. We operate in a LEAN orientated environment and you will have the opportunity to contribute with ideas and improvements and to drive the implementation of these. Working within QA your professional and individual skills will be challenged and you will find that your tasks will include many different clinical stages in the product development.
Qualifications
You hold a Master’s degree in Pharmacy, Chemical Eng. or possess equivalent qualifications besides a strong quality mindset. You have at least a few years of experience within QA or other related disciplines. The ideal candidate has thorough knowledge within one or more of following areas: GMP, validation, equipment qualification, regulatory requirements to validation/qualification in pilot plants for investigational medicinal products for use in clinical trials and LEAN skills. You are fluent written and spoken Danish and English on a professional level. With your good cooperation and communication skills you are able to organise and drive tasks. You take a pragmatic approach to problem solving and have strong interpersonal skills. You are detail-oriented with a strong quality mind set and are a team player, but also able to work independently. You thrive on working across departments in an international organisation. We look for an open minded person with an outgoing attitude, natural networking skills. And we would enjoy having a straightforward person with a good sense of humour in our department.
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 Peter Søtofte Elten at +45 3079 8453.
Deadline
23 November 2013.