CMO Quality Manager (m/f/d) – freelance – on hold

  • Position zu besetzen ab 7. Oktober 2019
  • Permanent-ID OCR-FL-805
  • Branche Pharma
  • Beschäftigungsform Freelance/ Contracting
  • Standort Deutschland / 6x
  • Kategorien Beschäftigungsform, Biotechnologie, Branche, Freelance/Contracting, Pharma

Tasks
CMO Quality Manager support with Product Data Sheets, Deviations and Complaints, Change Controls
o directs and approves deviations, investigations, CAPA completion and change control. Trackwise knowledge needed
o Generation of Product safety data sheets according to current existing layouts (Excel knowledge needed)
o responsible for development of Product Quality Reviews, compilation and evaluation of trends regarding drug product quality
o participates in and provides support to cross-functional teams in relation to product investigation, regulatory audits/inquires, implementation of new/revised GxP guidelines and improvement initiatives
o responsible for development and maintenance of quality agreements (Word knowledge needed)

 

Skills
o Development of Product Quality Reviews, compilation and evaluation of trends regarding drug product quality
o Trackwise knowledge / directs and approves deviations, investigations, CAPA completion and change control
o Support to cross-functional teams in relation to product investigation, regulatory audits/inquires, implementation of new/revised GxP
o Excel knowledge / Generation of Product safety data sheets according to current existing layouts
o Word knowledge / responsible for development and maintenance of quality agreements
o English: Business Fluent
o German: nice to have

 

Additional Information
Location: Darmstadt
Project start: 07.10.2019
Duration: about 5 months
Availability: 3 days / week
Remote: tbd.

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