Job Description

The Qualified Person (QP) certifying the finished product is responsible for ensuring that each finished medicinal product batch has been manufactured in accordance with GMP, the terms of the MIA (Manufacturing and Import Authorization), and the MA (Marketing Authorizations). Also included is the responsibility of the release of blood plasma and all further intermediates according to Annex 14

Your job:

  • Perform EU QP certification for all products under Prothya Biosolutions B.V. responsibility including products of contractpartners
  • Ensure Quality Compliance with all National and International Regulations and internal company regulations
  • Oversight of QMS (Quality Management Reviews), which includes Quality Management Reviews, Quality Agreements, Product Quality Reviews
  • Maintenance of the Manufacturing License
  • Approve Product Quality Complaints related investigations
  • Cooperate with all necessary departments to ensure that comm...

    • Ready to Apply?

    Take the next step in your AI career. Submit your application to Prothya Biosolutions today.

    Submit Application