Swapnil Priyadarshni's Linkedin Analytics

End to End Validation planning and Project execution for IT systems in GxP (GCP, GMP, GLP) Area. Good knowledge about 21 CFR part 11, EU Annex 11. Review and Approve GxP document. Conduct Software system validation activities for core software applications and customized solutions within agreed timelines. GxP and Risk Assessment Working with both CQA and IT departments on validation front. Conduct comprehensive IT systems validation in close cooperation with all involved departments within IT projects: work closely with project team members and IT vendors throughout the entire IT system/ software development life cycle. Guide project team to deliver as per FDA guidance. Worked with CQA team for updating the change management SOP Responsible for defining/documenting validation strategy for GxP IT systems. CSV Documents (Validation Plans, Validation Reports, Release Plans, and Release Reports, Requirements, Designs, Test Plans, Test Scripts, Requirements Traceability Matrix, Test Results, and Test Summary Reports) Performed Periodic review of GxP System. Change Management and Incident Management Involved in documentation of Lifecycle development for CSV (IQ, OQ, PQ) and SDLC processes. 21 CFR PART 11, GAMP 5 Guidelines.