IN-Senior Associate_CSV_ITRA_Advisory_Mumbai
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Job Description
Structured overview of role & requirementsAbout This Role
Own and execute Computer System Validation (CSV) activities including authoring deliverables such as Validation Plans, URS, FRS, IQ/OQ/PQ protocols, Validation Summary Reports.
Conduct manual software testing across SDLC stages (positive/negative testing, regression, smoke, sanity testing) with defect tracking and reporting.
Ensure compliance with relevant regulations and guidelines (GAMP5, GxP, US FDA 21 CFR Part 11, EU Annex 11, ALCOA+ principles) in validation and IT compliance processes.
Minimum Requirements
4 to 12 years of work experience in Computer System Validation (CSV), software testing, and IT compliance.
Bachelor of Technology or Bachelor of Engineering degree mandatory; any UG/PG education acceptable but B.Tech/B.E preferred.
Experience with SDLC methodologies including Waterfall, Agile, and V model specific to CSV.
Knowledge of GAMP5 Guideline, GxP, US FDA 21 CFR Part 11, EU Annex 11, ALCOA+ principles and experience with version control aspects like Change Control, Deviation Management, CAPA, and Periodic Review.
Ideal Candidate Profile
Experienced in manual testing techniques and defect management within regulated environments.
Familiar with authoring and managing end-to-end CSV documentation and protocols aligned with compliance standards.
Preferably has exposure to CSV tools such as Valgenesis and knowledge of LIMS/QMS systems.