ID EXISTS
POS 2830
Status 10
DJM 1

Quality Assurance Manager GMP EU Guideline

Beschreibung: One of our pharmaceutical clients in the Cologne area is looking for freelance support: Quality Assurance Manager GMP EU Guideline (M/F/D)
Tasks:
  • Maintain an overview and consistently monitor contractual partners
  • Check of the manufacturer’s / product’s compliance with the marketing authorization
  • Check fulfilment of regulatory commitments
  • Check of existing change controls and their status
  • Overview of Outsourcing activities
  • Vendor Management
  • Oversight of Recalls and updating Quality Agreements
  • Review/Assessment of Product Quality Review
  • Contact person for relevant authorities
  • Ensure the security and GMP compliance at manufacturers
  • Ensure control of labelling and packaging
Qualification:
  • Start: asap, latest April 1st / 12 months / 2,5 - 3 days per week
  • Experienced with quality management for manufacturing licencing
  • Very good knowledge of relevant EU regulation such as EU GMP Chapter 5,7-8, Annex 16; Directive 2001/83 EC
  • Very good knowledge of GMP supply chains
  • Experience CMO Manager
  • Relevant audit experience
  • Business fluent in German and English
Bemerkungen: WANTED: Quality Assurance Manager GMP EU Guideline (M/F/*). Please contact +49 89 18 90 998 11 or stefanie.bauer@k-recruiting.com Skills: Auditor, CMO Management (Contract Manufacturing), English, German, GMP (Good Manufacturing Practice), Pharma, QA (Quality Assurance)

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