Quality Assurance Professional for Clinical Trials in API Development

2 weeks ago


Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

About the Opportunity

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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 member of this dynamic team, you will be responsible for ensuring compliance with regulatory requirements, quality standards, and company policies.

Your Key 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.

Required Skills and Qualifications

  • 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 You

You are a self-driven and independent person with a high sense of responsibility and initiative who can prioritize your many different tasks. You thrive in a dynamic environment, where teamwork is on the top of the agenda, and like working with many different stakeholders – internally and externally.

Earnings and Benefits

The estimated salary for this position is around €60,000 - €80,000 per annum, depending on your qualifications and experience. In addition to a competitive salary, we offer a range of benefits, including health insurance, pension scheme, and opportunities for professional development.

Our Team and Culture

We are a team of skilled and motivated colleagues who value teamwork, diversity, and humor very high. We will make sure you, as a new employee, feel welcome and integrated into our team. Further, a thorough individual training plan will be made together with your mentor.



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