Global QA Specialist for Finished Product Local CMOs

7 days ago


Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

Job Details

The job involves working with Contract Manufacturing Organizations (CMOs) located around the world to ensure QA oversight by activities such as visits at the CMO, compliance checks, approval of QMS documents, and release of Novo Nordisk insulin products to the market.

You will be part of a highly skilled QA team that delivers best-in-class Quality Assurance and ensures the highest quality at our CMOs production.

Main Responsibilities

  • You will handle daily operations such as approval of change requests, deviations, and batch release, as well as supporting in all quality matters.
  • You will build the Quality mindset as well as Quality and Compliance culture at the CMO.
  • You will train the local CMO QA organization to maintain and improve compliant operations.
  • You will engage and energize local employees at the CMOs.

Requirements

  • You should hold an academic degree within Pharmacy, Chemistry, Biochemistry, Biotechnology Engineering or similar.
  • You should have some relevant experience working with either aseptic processes, assembly, or packaging production in organizations within pharmaceutical manufacturing (either as QA or production).
  • You should have a high level of knowledge within Quality, QMS, and EU GMP requirements.
  • You should have gained said experience within the pharmaceutical or medical devices industry.
  • You should be fluent in English, both written and spoken.


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