Having 4-8 years of work experience in Computer System Validation (CSV), Software Testing and IT Compliance.
Exposure in Software Development Life Cycle (SDLC) and Software Testing Life Cycle (STLC).
Knowledge of SDLC methodology like Waterfall and Agile model and V model of CSV.
Experience in manual testing like Positive & Negative Testing, Regression Testing, Smoke, Sanity Testing and defect tracking and reporting. (Preferred exposure to CSV tools such as Valgenesis)
Knowledge of GAMP5 Guideline, GxP, US FDA 21 CFR Part 11, EU Annex 11 and ALCOA+ principles.
Knowledge of Change Control, Deviation Management, CAPA and Periodic Review.
Experience in authoring Computer System Validation deliverables like GxP Assessment, Validation Plan (VP), User Requirement Specifications(URS), Functional Requirement Specifications(FRS), Fun...