QA Professional, CMC Analysis QA
- Quality
- Denmark - Måløv
CMC Analysis QA within R&D, Novo Nordisk A/S, Måløv, is seeking a QA Professional with drive and personality. Would you enjoy the high activity of the QA work within a broad spectrum of Novo Nordisk quality? 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
In Chemistry, Manufacturing & Control (CMC) Analysis QA we ensure that all analysis activities for all Novo Nordisk development projects live up to cGMP requirements. The development portfolio is expanding and thus we seeking a new colleague to help us support the growth. 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 proactively 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 within QA or other related disciplines. The ideal candidate has thorough knowledge within one or more of following areas: GMP, analysis validation, analysis equipment qualification, regulatory requirements to analysis for investigational medicinal products for use in clinical trials and LEAN skills. Qualifications within IT equipment system regulatory requirements will also be regarded as a plus. 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, 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 Pernille Uldall Bolvig +45 3079 7548.
Deadline
10 October 2013
- Quality
- Denmark - Måløv
CMC Analysis QA within R&D, Novo Nordisk A/S, Måløv, is seeking a QA Professional with drive and personality. Would you enjoy the high activity of the QA work within a broad spectrum of Novo Nordisk quality? 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
In Chemistry, Manufacturing & Control (CMC) Analysis QA we ensure that all analysis activities for all Novo Nordisk development projects live up to cGMP requirements. The development portfolio is expanding and thus we seeking a new colleague to help us support the growth. 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 proactively 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 within QA or other related disciplines. The ideal candidate has thorough knowledge within one or more of following areas: GMP, analysis validation, analysis equipment qualification, regulatory requirements to analysis for investigational medicinal products for use in clinical trials and LEAN skills. Qualifications within IT equipment system regulatory requirements will also be regarded as a plus. 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, 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 Pernille Uldall Bolvig +45 3079 7548.
Deadline
10 October 2013