CSV Consultant / Lead

-Should have minimum 8 to 12 years of experience on GAMP Category 4 and 5 systems
- Should have good verbal and written communication
- Should have sound knowledge on 21 CFR part 11, GAMP5, Risk Assessment Tools
- Should have good experience in preparation of documents: Functional Specification, Validation Plan, IQ, OQ, PQ Protocols and Test Scripts, Traceability Matrix & Validation Summary Report
- Ability to Analyze the Impact Assessment, System, Functional and Security Level Risks and to able to provide Risk Mitigation.
- Should have good knowledge to review and providing guidance to End-Users to create/update the documents of URS, GxP Assessment, Functional Specification, Design & Architecture, System Configuration documents.
- Ability to guide users on quality process of Change control, Deviations/Incidents/Exceptions raising and closing, SOP preparations, IQ, OQ and PQ executions
- Ability to provide end-user training on respective application usability