Quality Assurance Professional for Clinical Trials

2 days ago


Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time
About the Role

We are seeking a highly motivated and experienced Quality Assurance Professional to join our CMC API QA team at Novo Nordisk A/S. As a key member of our team, you will be responsible for ensuring compliance with regulatory requirements, quality standards, and company policies in the raw material and CMO shipping area.

Responsibilities
  • 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 Salary

The estimated annual salary for this role is approximately DKK 650,000 - DKK 800,000, depending on qualifications and experience. This includes a range of benefits such as pension scheme, health insurance, and paid time off.

About the Department

Clinical Trials at Novo Nordisk A/S involve ensuring that our products meet the highest standards of quality and safety. Our department employs 35 skilled and motivated colleagues who work together to achieve this goal. We value teamwork, diversity, and humor and offer a dynamic work environment where you can grow and develop your skills.



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