Senior QA Manager / Qualified Person

  • Salary: Competitive
  • REF Number: 00047797
  • Consultant: Jocelyn Blackham
  • Contact: 0041 (0) 782 516 595
  • Date Published: 02.03.2020
  • Sector:
  • Location: Basel Area
  • Discipline: Science - QA/Validation

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.

Company:

This company specialised in the producing and distributing pharmaceutical products worldwide.

Location:

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

Your Background:

  • 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 jblackham@ckqls.ch, quoting job ref 47797

It is essential that applicants hold entitlement to work in Switzerland

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