Technical QA Manager Annex 1 Project | Technischer QA Manager Annex 1 Projekt

Job Summary

This is a critical contract opportunity for an experienced Technical QA Manager to join the IMP Quality - Qualification/Validation Team at a leading pharmaceutical company in Basel. Focusing specifically on the Annex 1 Project concerning sterile filling operations, you will ensure the GMP compliance of existing and new equipment and systems. Key responsibilities include providing QA oversight for qualification and validation activities related to GMP-relevant systems, including CSV systems, and supporting the implementation of data integrity requirements. You will be responsible for reviewing and approving crucial GMP documentation such as qualification plans, reports, change/deviation management, CAPAs, and SOPs. This role demands collaboration with diverse stakeholders, representing the area during health authority inspections and internal audits, and requires proven success in navigating regulatory scrutiny. Fluency in both German and English is a mandatory prerequisite for success in this highly regulated environment.