Gagan Gagan

I am an achievement-driven post‑graduate Life Science professional with 3.6 years of experience in computerized system validation (CSV), quality assurance, and regulatory compliance across pharmaceutical and biotech environments. I have hands‑on experience creating URS, test plans, OQ/PQ/SAT execution, risk assessments (FMEA), and maintaining CSV documentation aligned to GAMP5, ALCOA++ and 21 CFR Part 11.

I collaborate closely with stakeholders and developers to translate user stories into detailed test cases, execute regression and migration testing, log defects and produce test reports, and support vendor qualification and equipment commissioning/qualification. I hold CSV and Agile certifications and have contributed to successful regulatory audits including USFDA, TGA and MHRA recognitions.