Senior Quality Assurance Specialist in CMC API QA

1 month ago


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

We are seeking a highly motivated and experienced Senior Quality Assurance Professional to join our CMC API QA team. The successful candidate will serve as 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.
  • Challenge and approve documents related to the development, manufacture, stability, and status assignment of internal and external produced API.
  • Ensuring that our products used in clinical trials are following the information provided to Health Authorities worldwide.
  • Participate in regulatory inspections and audits and ensure compliance with cGMP and other regulatory requirements.
About the Department

CMC API QA is a department that 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, as well as the release of API for all clinical trials within Novo Nordisk.

Qualifications
  • A Master 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.
  • A profound understanding of the important aspects of regulations, requirements, and guidelines for pharmaceutical development and production.
  • Proficiency in English and Danish.
  • Proficiency in SAP and/or PasX along with experience with API and CMOs, will be seen as an advantage.
About Novo Nordisk

At Novo Nordisk, we don't wait for change. We drive it. We're a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection.



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