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Tier-1 brand and metro location boost applicant density despite niche CSV/GxP specialization.
Role requires specialized GxP/CSV regulatory expertise, limiting cross-industry transferability.
Mandatory 4-12 years plus specific CSV/GxP regulatory experience and deliverable authoring makes filters strict.
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Own end-to-end Computer System Validation (CSV) activities including authoring validation deliverables such as Validation Plan, URS, FRS, IQ/OQ/PQ protocols, and Validation Summary Report.
Perform software testing (manual testing including regression, smoke, sanity, positive and negative testing) and defect tracking to ensure compliance with IT and regulatory standards.
Apply knowledge of GAMP5 guidelines, GxP, US FDA 21 CFR Part 11, EU Annex 11, and ALCOA+ principles to support compliance and risk management within IT systems.
4-12 years of work experience in Computer System Validation (CSV), Software Testing, and IT Compliance.
Bachelor of Technology or Bachelor of Engineering degree mandatory.
Proficient understanding of Software Development Life Cycle (SDLC) models including Waterfall, Agile, and V model of CSV.
Knowledge of regulatory and compliance standards including GAMP5, GxP, US FDA 21 CFR Part 11, and EU Annex 11.
Experienced in manual software testing methodologies and defect tracking, with exposure to CSV tools such as Valgenesis preferred.
Capable of authoring and managing comprehensive CSV documentation and validation protocols aligning with regulatory guidelines.
Comfortable operating within regulated environments requiring adherence to change control, deviation management, CAPA, and periodic review processes.