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Tier-1 employer, metro location, and mid-level experience bracket increase applicant competition despite niche CSV skills.
GxP, FDA 21 CFR and Annex 11 expertise ties role strongly to pharma and regulated industries.
Explicit 4-8 years plus mandatory CSV, GxP and regulatory deliverables create highly stringent filters.
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Accountable for Computer System Validation (CSV) activities including authoring deliverables such as Validation Plans, URS, FRS, IQ/OQ/PQ protocols, and Validation Summary Reports.
Perform manual testing including Positive & Negative Testing, Regression, Smoke, and Sanity Testing, as well as defect tracking and reporting within SDLC and STLC frameworks.
Ensure compliance with GAMP5 guidelines, GxP, US FDA 21 CFR Part 11, EU Annex 11, ALCOA+ principles and manage Change Control, Deviation Management, CAPA, and Periodic Review.
4 to 8 years of experience in Computer System Validation (CSV), Software Testing, and IT Compliance.
Bachelor's degree in Pharmacy (B.Pharm) or Bachelor of Engineering.
Knowledge of SDLC methodologies including Waterfall, Agile, and V-model as applied to CSV.
Familiarity with regulatory standards such as GAMP5, GxP, US FDA 21 CFR Part 11, and EU Annex 11.
Experienced in authoring and managing full CSV documentation and validation lifecycle in regulated environments.
Comfortable working with manual testing techniques and defect tracking within structured SDLC/STLC processes.
Knowledge of CSV tools (e.g., Valgenesis) and preferred exposure to LIMS/QMS systems enhances competitive fit.