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Advanced Quality Assurance Specialist
2 months ago
About the Role
We are seeking a highly motivated and experienced Quality Assurance Professional to join our Chemistry, Manufacturing and Control (CMC) Active Pharmaceutical Ingredients (API) QA team at Novo Nordisk.
Key Responsibilities
- Ensure compliance with regulatory requirements, quality standards, and company policies in the CMC API Development area.
- Support the development of raw materials for clinical trials, ensuring that they meet the required quality standards.
- Participate in regulatory inspections and audits, and ensure compliance with cGMP and other regulatory requirements.
- Secure quality agreements with external suppliers and ensure that they meet the required quality standards.
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
Our CMC API QA department 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
- A dynamic and collaborative work environment.
- A thorough individual training plan to ensure your success in the role.
- The opportunity to work with a talented team of professionals who share your passion for quality and compliance.
