Quality Assurance Expert for API Clinical Trials

11 hours ago


Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

About the Role

We are seeking a highly motivated and experienced Senior Quality Assurance Professional to join our CMC API QA team as a QP delegate, primarily responsible for releasing internal and externally produced API for usage in the Novo Nordisk clinical trial pipeline.

Key Responsibilities:

  • Ensuring best-in-class quality assurance of our API for clinical trials in phase I, II, and III testing.
  • Challenging and approving documents related to the development, manufacture, stability, and status assignment of internal and external produced API.
  • Ensuring that our products used in clinical trials comply with regulatory requirements and information provided to Health Authorities worldwide.
  • Participating in regulatory inspections and audits and ensuring compliance with cGMP and other regulatory requirements.

About Us

Novo Nordisk is a dynamic company in an even more dynamic industry. We're committed to creating an inclusive culture that celebrates diversity and supports the growth of our employees. As part of our CMC API QA team, you will be responsible for safeguarding patient safety and ensuring product quality and compliance in the CMC area.

Requirements

  • A Master's degree in Pharmacy, Engineering, Biology, Chemistry, or similar to fulfill the requirements to become a 'Qualified Person' (QP), according to The Danish Medicines Agency certification.
  • Extensive experience in a pharmaceutical company, ideally also in a QA role.
  • Proficient in English and Danish.
  • Proficiency in SAP and/or PasX along with experience with API and CMOs will be seen as an advantage.

Salary and Benefits

The estimated salary for this role is approximately 120,000 DKK per annum, based on industry standards and location. As a member of our team, you will enjoy a range of benefits, including access to training and development opportunities, a comprehensive pension scheme, and a flexible working environment.

Contact Information

Please contact QA Manager Michael Kongsgaard for further information about this exciting opportunity.



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