Senior Quality Assurance (QA) Manager (gn)

München  ‐ Vor Ort
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Beschreibung

You have in-depth experience in Quality Assurance (QA) in the pharmaceutical industry and are looking for a jump to an international biotech company in Munich? Then the following role should be very interesting for you:
(Senior) Manager Quality Assurance (m/f/d)

Your Responsibilities:
  • Plan, perform and follow-up audits of external Contract Manufacturing/Contract Testing Organizations
  • Support CMC department in selecting external CMO/CTO
  • Setting-up of Quality-Technical Agreements (QTA) including negotiating with CMO/CTO, and external Pharmacies, update of existing QTA
  • Set-up batch release processes for clinical trial material produced outside EU for use in clinical trials conducted world-wide
  • Managing of GMP deviations, changes, out-of-specifications occurring at external CMO/CTO
  • CAPA Management


Your Profile:
  • Professional experience in GMP Quality Assurance within (bio)-pharmaceutical industry
  • Sound knowledge in international regulations and guidelines (EU / FDA cGMP regulations, GDP guidelines, ICH etc.)
  • Sound background in bioprocessing is a plus
  • Able to work independently and solution-oriented
  • Well-organized, structured person with attention to detail
  • Excellent communication skills, fluent in English (written and spoken)
  • Flexible, highly motivated, with strong organization skills
  • Team player with well-developed interpersonal abilities
  • Excellent application of office software (Word, Excel, PowerPoint and SharePoint)


Are you interested in this place? Then I look forward to your application.

Best wishes,

Stefan Blöchl
Start
05/2021
Von
Progressive IT
Eingestellt
05.03.2021
Projekt-ID:
2062833
Vertragsart
Freiberuflich
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