PSC Biotech Corporation

Analyst

• Review pre‑executed SAP GxP test scripts for completeness, clarity, and alignment to requirements.
• Review post‑executed test scripts for accuracy, proper evidence, deviations, and approvals.
• Support test deviation management process.
• Ensure documentation complies with FDA 21 CFR Part 11, Annex 11, GAMP 5, ALCOA+, and client validation procedures.
• Collaborate with US QA, IT, and business teams on validation cycles and audit readiness.

SAP Computer System Validation Analyst