Quality Validation Specialist (GMP, CSV)

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.

• 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