CQV

About the role

The role involves ensuring compliance with applicable standards (ISPE Baseline Guides, ASTM E2500, EU Annex 15, 21 CFR Part 11) and supporting project delivery by providing technical expertise and documentation in line with client procedures. Prepare, review, and execute CQV documentation including URS, DQ, FAT/SAT, IQ/OQ/PQ protocols, summary reports, and related deliverables.

What you'll do

• Prepare, review, and execute CQV documentation including URS, DQ, FAT/SAT, IQ/OQ/PQ protocols, summary reports, and related deliverables
• Support development of test scripts and acceptance criteria for mechanical, electrical, automation, and process systems
• Verify that systems meet design and regulatory requirements prior to release for GMP use
• Ensure all activities comply with regulatory expectations and client quality systems
• Support internal and external audits by providing documentation and technical explanations as required

What you need

• GMP
• Documentation
• Safety management
• Any graduate