Pwc
INSeniorAssociateCSVITRAAdvisoryAhmedabad
“IN-Senior Associate_CSV_ITRA_Advisory_Ahmedabad at Pwc. Skills: Computer System Validation, Software Testing, IT Compliance. Author Computer System Validation deliverables. Perform GxP Assessment”
What They're Looking For.
Must Have
4-8 years work experience in Computer System Validation (CSV), 4-8 years work experience in Software Testing, 4-8 years work experience in IT Compliance, Exposure in Software Development Life Cycle (SDLC), Exposure in Software Testing Life Cycle (STLC), Knowledge of SDLC methodology like Waterfall, Knowledge of SDLC methodology like Agile model, Knowledge of V model of CSV, Experience in manual testing, Experience in defect tracking and reporting, Knowledge of GAMP5 Guideline, Knowledge of GxP, Knowledge of US FDA 21 CFR Part 11, Knowledge of EU Annex 11, Knowledge of ALCOA+ principles, Knowledge of Change Control, Knowledge of Deviation Management, Knowledge of CAPA, Knowledge of Periodic Review, Experience in authoring Computer System Validation deliverables, Bachelor of Engineering
Nice to Have
Preferred exposure to CSV tools, MBA
What You'll Do.
Author Computer System Validation deliverables
Perform GxP Assessment
Develop Validation Plan (VP)
Develop User Requirement Specifications(URS)
Develop Functional Requirement Specifications(FRS)
Perform Functional Risk Assessment (FRA)
Develop Design Specifications (DS)
Develop IQ/OQ/PQ protocols
Develop Validation Summary Report (VSR)
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