Academic for Quality Assurance of API Development
- Quality
- Denmark - Gentofte
Do you want to unfold your profound QA knowledge and your huge appetite for creating results in a pharmaceutical production environment? If so, please apply for the position as QA Academic in a job that includes many different clinical stages of the product development.
About the department
In Chemistry, Manufacturing & Control (CMC) API QA we assure that each and every Active Pharmaceutical Ingredient (API) activity in our development and support projects live up to the cGMP requirements. The development portfolio is expanding and thus we seeking a new colleague to help us support the growth.We are 29 colleagues in three teams. You will join the downstream team and have 12 dedicated colleagues. Our mission is to assure that our manufacturing processes, intermediates and finished API (purification and chemical synthesis) meet the internal and external requirements. Furthermore we’re responsible for release of API for all of Novo Nordisk’s clinical trials. The production facilities and the development laboratories are located in Bagsværd, Gentofte and Måløv, and you will move between the different locations and the QA office on a day-to-day basis.
The Job
You assure best-in-class quality of our new manufacturing processes and API for clinical trials. Document approval in connection with development, manufacture, stability and release of API for clinical trials as well as maintenance and improvement of the quality system (SOP’s) will constitute some of your daily tasks. In addition, you will participate in our development projects and in close cooperation with your colleagues you identify and contribute to the strengthening our stakeholders’ compliance level and act as a consultant for them.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, and you will find that your tasks cover many different clinical stages of the product development.
Qualifications
You hold a Master’s degree in Pharmacy, Chemical Engineering or possess equivalent qualifications besides a strong quality mindset. You have at least 3 years’ experience with GMP, product release, production or quality assurance. As we operate in an international environment, you must speak and write English fluently.You are ambitious and determined on creating world-class results and ensure quality of the highest order. Moreover, you thrive in a role where you use your knowledge and bring your arguments and negotiation skills into play. You are able to adapt but also challenge our way of working so that we constantly improve our methods and processes.
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.
Contact
For further information, please contact Peter Søtofte Elten at +45 3079 8453.
Deadline
06 October 2013.
- Quality
- Denmark - Gentofte
Do you want to unfold your profound QA knowledge and your huge appetite for creating results in a pharmaceutical production environment? If so, please apply for the position as QA Academic in a job that includes many different clinical stages of the product development.
About the department
In Chemistry, Manufacturing & Control (CMC) API QA we assure that each and every Active Pharmaceutical Ingredient (API) activity in our development and support projects live up to the cGMP requirements. The development portfolio is expanding and thus we seeking a new colleague to help us support the growth.We are 29 colleagues in three teams. You will join the downstream team and have 12 dedicated colleagues. Our mission is to assure that our manufacturing processes, intermediates and finished API (purification and chemical synthesis) meet the internal and external requirements. Furthermore we’re responsible for release of API for all of Novo Nordisk’s clinical trials. The production facilities and the development laboratories are located in Bagsværd, Gentofte and Måløv, and you will move between the different locations and the QA office on a day-to-day basis.
The Job
You assure best-in-class quality of our new manufacturing processes and API for clinical trials. Document approval in connection with development, manufacture, stability and release of API for clinical trials as well as maintenance and improvement of the quality system (SOP’s) will constitute some of your daily tasks. In addition, you will participate in our development projects and in close cooperation with your colleagues you identify and contribute to the strengthening our stakeholders’ compliance level and act as a consultant for them.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, and you will find that your tasks cover many different clinical stages of the product development.
Qualifications
You hold a Master’s degree in Pharmacy, Chemical Engineering or possess equivalent qualifications besides a strong quality mindset. You have at least 3 years’ experience with GMP, product release, production or quality assurance. As we operate in an international environment, you must speak and write English fluently.You are ambitious and determined on creating world-class results and ensure quality of the highest order. Moreover, you thrive in a role where you use your knowledge and bring your arguments and negotiation skills into play. You are able to adapt but also challenge our way of working so that we constantly improve our methods and processes.
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.
Contact
For further information, please contact Peter Søtofte Elten at +45 3079 8453.
Deadline
06 October 2013.