QA Manager Process Validation

Thun  ‐ Vor Ort
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Beschreibung

QA MANAGER PROCESS VALIDATION

Location: South of Switzerland- 3 days per week

Duration: 6 months initially

Summary

The QA will be responsible for manufacturing process validation in the biopharmaceutical plants, including process characterization, validation activities at scale, continued process verification and Product Quality Reviews (PQRs).

Accountabilities
  • Ensure the manufacturing processes: APIs and Intermediates are in a validated state during their whole lifetime according to the companies procedures, and in compliance with regulatory guidance
  • Preparation of comprehensive process specific Validation Master Plans, describing the individual studies required for process validation
  • Leading the process validation teams including communication with customers
  • Support R&D teams during the process design phase
  • Preparation of the validation protocols and reports for the studies performed at manufacturing scale
  • Assessment of changes and deviations during manufacturing for their impact on validation


Candidate profile
  • Education: Master Degree in Chemistry or Biotechnology (PhD preferred)
  • Experience:
    • Proficiency in writing scientific reports in English
    • Experience in GMP manufacturing preferred
  • Languages: Fluency in English
  • General skills:
    • Excellent communication skills
    • Challenges the status quo and looks for opportunities to make improvements in his/her area of the business and beyond
    • Managing internal and external customer relations professionally and effectively


Keywords: QA Manager Process Validation, QA, Process Validation, Thun, Berne, Switzerland, Pharmaceuticals, biopharmaceutical, process verification, PQR, API, Validation Master Plan, Chemistry, Biotechnology, GMP, Manufacturing

Sthree Switzerland is acting as an Employment Business in relation to this vacancy.
Start
10/2023
Von
Real Staffing
Eingestellt
20.09.2022
Projekt-ID:
2465102
Vertragsart
Freiberuflich
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