Senior QA Manager / Qualified Person
CK QLS are recruiting for a Senior QA Manager / Qualified Person to join an international pharmaceutical company at their site based in Basel on a either a contract (adhoc) or permanent basis.
This company specialised in the producing and distributing pharmaceutical products worldwide.
This Senior QA Manager / Qualified Person role will be based at our clients site in Basel.
Senior QA Manager / Qualified Person Role:
- Act as Qualified Person acc. to §14 German Drug Medicine Law
- Be responsible for rejection / batch certification of medicines for batches manufactured by CMOs (release to market)
- Manage recall and notifications from regulatory agencies in close collaboration with the operational quality unit
- Act as point of contact for internal and external questions regarding QA
- Maintain and further develop the PQS to ensure GMP/GDP compliance with the requirements for APIs, intermediates and finished products manufactured by CMOs
- Qualification as Qualified Person acc. to §15 German Drug Medicine Law
- Previous professional experience in QA / QC or pharmaceutical production
- Solid experience as an internal or external auditor
- Very good knowledge of QA and GMP / GDP guidelines
- Fluent in German and English is mandatory
Apply: For more information or to apply for this Senior QA Manager / Qualified Person position, please contact Jocelyn on 0041 (0) 782 516 595 or email firstname.lastname@example.org, quoting job ref 47797
It is essential that applicants hold entitlement to work in Switzerland