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Tier-1 brand and metro location increase competition, but niche CSV skillset limits applicant density.
Role requires regulated-industry CSV and GxP/FDA expertise, limiting cross-industry transferability.
Mandatory 4–8 years CSV experience and regulatory expertise (GxP, FDA, URS/IQ/OQ/PQ) increases shortlisting strictness.
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Own and execute Computer System Validation (CSV) activities including validation planning, requirement specification, risk assessment, and protocol authoring (IQ/OQ/PQ).
Perform manual software testing covering positive/negative, regression, smoke, and sanity tests along with defect tracking and reporting.
Ensure compliance with industry regulations and guidelines such as GAMP5, US FDA 21 CFR Part 11, EU Annex 11, ALCOA+ principles, and quality management processes like Change Control, CAPA, and Periodic Review.
4-8 years of work experience in Computer System Validation (CSV), Software Testing, and IT Compliance.
Educational qualification: Bachelor of Engineering or B.Pharm degree.
Knowledge of Software Development Life Cycle (SDLC) methodologies including Waterfall, Agile, and V-model.
Familiarity with GAMP5 guidelines, GxP, US FDA 21 CFR Part 11, EU Annex 11, ALCOA+ principles, and experience authoring CSV deliverables.
Experienced in CSV execution within regulated industries, demonstrating proficiency in both CSV documentation and manual software testing.
Comfortable working with SDLC and testing methodologies across Waterfall, Agile, and V-model frameworks.
Capable of managing regulatory compliance through use of tools like ValGenesis and familiarity with LIMS/QMS systems.