Quality Assurance Specialist for Process Validation

4 weeks ago


Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

About the Job:

We are seeking a highly skilled Quality Assurance and Validation Specialist to join our team at Novo Nordisk A/S.

Key Responsibilities:

  1. Set the quality direction for the capacity expansion project
  2. Deliver best-in-class quality for qualification of equipment/facilities and IT-systems
  3. Handle larger and complex quality issues
  4. Ensure a LEAN culture and drive improvement activities across areas
  5. Represent CMC QA in cross-organisational groups in Novo Nordisk

Requirements:

  1. Hold a Master in Pharmacy, Engineering, Biology, Biotechnology, Chemistry or similar
  2. Have at least 7 years of experience in QA roles in the pharmaceutical industry
  3. Ideally have experience within validation of GMP facilities and equipment
  4. Have a flair for IT
  5. Be fully proficient in English

About the Department:

CMC API QA is a department which employs over 40 skilled and motivated colleagues divided into 4 teams all based in Site Bagsværd.

We work with assuring quality and compliance of the CMC API facilities & equipment and release of raw materials, cell banks and API for clinical trials.



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