CSV Documentation Intern
- Supported full Computer System Validation (CSV) lifecycle, following GAMP5 guidelines.
- Drafted and reviewed key validation documents: URS, FS/FRS, RA, VP, IQ/OQ/PQ, and VSR.
- Worked with QA and engineering teams to ensure 21 CFR Part 11 compliance and data integrity.
- Implemented traceability matrices and assisted with risk-based testing.