Job Description

Key Responsibilities:

Quality Oversight & Compliance

  • Provide QA oversight for CSV activities in accordance with cGMP, GAMP 5, 21 CFR Part 11, Annex 11, and company quality policies.
  • Ensure project activities adhere to data integrity principles, including ALCOA+ requirements.
  • Review and approve validation deliverables such as:
  • User Requirements Specifications (URS)
  • Functional Specifications
  • Risk assessments
  • IQ/OQ/PQ protocols and reports
  • Test deviations, incidents, and change controls

Project Team Participation

  • Serve as the QA representative on project teams for system upgrades, replacements, and new system implementations.
  • Ensure project schedules account for appropriate QA activities, validation timelines, and regulatory requirements.
  • Identify quality and compliance risks early and ensure timely escalation to the Department Manager.

Stakeholder...

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