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Tier-1 employer and metro location increase competition, but niche CSV skillset limits applicant density.
Role requires GxP/CSV regulatory expertise, making skills industry-specific and less transferable.
Explicit 4–8 years plus mandatory CSV, GxP, and validation deliverables make filters strict.
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Own computer system validation (CSV) activities including development and review of validation deliverables (e.g., URS, FRS, IQ/OQ/PQ protocols, Validation Summary Reports) conforming to regulatory requirements such as GAMP5, US FDA 21 CFR Part 11, EU Annex 11.
Conduct and manage manual software testing (positive/negative, regression, smoke, sanity) within SDLC/ STLC frameworks, using methodologies like Waterfall, Agile, and V model of CSV.
Ensure compliance with IT compliance standards through activities such as change control, deviation management, CAPA, and periodic review, supporting end-to-end internal audit and risk management processes.
4-8 years of work experience specifically in Computer System Validation (CSV), Software Testing, and IT Compliance.
Bachelor's degree required: Bachelor of Engineering or B.Pharm degree acceptable as per JD.
Mandatory knowledge of SDLC, STLC, CSV methodologies (Waterfall, Agile, V model), and regulatory standards including GAMP5, US FDA 21 CFR Part 11, EU Annex 11, and ALCOA+ principles.
Experience with CSV deliverables creation and manual testing practices; familiarity with CSV tools such as ValGenesis is preferred but not mandatory. Notice period: Not explicitly mentioned in the JD.
Experienced professional with strong domain expertise in CSV within regulated industries, capable of independently managing validation lifecycle and IT compliance tasks.
Pragmatic in applying SDLC/ STLC methodologies and testing techniques aligned with regulatory frameworks, comfortable working in audit-related advisory environments.
Capable of synthesizing compliance requirements with technical validation expertise to support governance and risk management functions in advisory or consulting roles.