The successful candidate will be responsible for reviewing validation lifecycle documentation and qualification deliverables across Equipment, Utilities, Facilities, and Automation Systems to ensure compliance with GMP requirements, site procedures, Annex 1 expectations, and industry best practices.
Key Responsibilities - Perform independent quality review of validation lifecycle documentation.
- Review Equipment Qualification deliverables including IQ, OQ, PQ protocols and reports.
- Review Utility Qualification documentation for GMP-critical utility systems.
- Review Facility Qualification documentation with focus on cleanroom and Annex 1 compliance requirements.
- Review Automation and Computer System Validation (CSV) documentation, including:
- Validation Plans
- User Requirements Specifications (URS)
- Functional Specifications (FS/DS)
- Risk Assessments
- Traceability Matrices