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Advanced Quality Assurance Specialist
1 month ago
About the Role
We are seeking a highly motivated and experienced Quality Assurance Professional to join our CMC API QA team. The successful candidate will support CMC API Development within the raw material and CMO shipping area.
Key Responsibilities
- Ensure compliance with regulatory requirements, quality standards, and company policies.
- Deliver best-in-class quality assurance of raw materials and CMO shipping area to our drug substance and drug product production for clinical trials.
- Challenge and approve documents in connection with raw materials and CMO shipping.
- Participate in regulatory inspections and audits and ensure compliance with cGMP and other regulatory requirements.
- Secure quality agreements with external suppliers.
Requirements
- MSc in Pharmaceutical Sciences, Engineering, Biochemistry or similar.
- At least 1 year of experience from the pharmaceutical industry within quality or production.
- Experience with GMP.
- Experience working with raw materials for API production.
- Proficiency in English.
- Proficiency in Danish is an advantage, but not a requirement.
About the Department
CMC API QA is a department which employs 35 skilled and motivated colleagues in four teams, all based in Bagsværd. We work with assuring quality and compliance of the CMC API facilities, equipment, quality management system, materials and the release of API for clinical trials.
What We Offer
We value teamwork, diversity and humor very high, and we will make sure you, as a new employee, feel welcome and integrated. Further, a thorough individual training plan will be made together with your mentor.
Contact
For further information, please contact Associate Manager Caroline Benedicte Kjærulff Mathiesen at Novo Nordisk A/S.