25h/80% remote – QA Manager for qualification and validation (m/f/n) – freelance – on hold

  • Position zu besetzen ab 23. Januar 2023
  • Permanent-ID OCR-FL-2163
  • Branche Pharma
  • Beschäftigungsform Freelance/ Contracting
  • Standort Deutschland / 6x
  • Kategorien Beschäftigungsform, Branche, Freelance/Contracting, Pharma

Tasks:
Consulting for qualification and validation with the aim of ensuring that systems, production facilities and premises are fit for purpose as well as providing evidence of the suitability of processes and procedures.
Consulting of qualification of chemical or pharmaceutical plants
Accompaniment of certification
Coordination and documentation of all Q&A and validation activities
Tracking of reports and deadlines
Preparation of a validation master plan
Advising the quality assurance unit on qualification and validation activities (IT and facilities)
System engineering for relevant GxP or non-GxP applications
Development of validation lifecycle documentation and templates, i.e. validation plan, test plan, validation report (English documentation)

Skills:
Excellent Knowledge in qualification of GMP facilities (min. 5 years)
Well-founded experience as QA Manager / Operations Assistant / Quality AssurerExcellent
Knowledge of qualification process for chemical- or pharma plants environment and / or accompanied during certification
Experience as a Project Manager is also advantageous
M. of Sc. / Engineer (Process engineering) or equal
Fluent english in a business context

Additional Information:
Location: remote / Darmstadt
Project start: February/March 2023
Duration: 12 months, 80% remote

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