Position Overview
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 contractpartnersEnsure Quality Compliance with all National and International Regulations and internal company regulationsOversight of QMS (Quality Management Reviews), which includes Quality Management Reviews, Quality Agreements, Product Quality ReviewsMaintenance of the Manufacturing LicenseApprove Product Quality Complaints related investigationsCooperate with all necessary departments to ensure that comm...