Working as project associate for computer system validation of life sciences domain.Experience in Computerized System Validation (CSV) of GxP and Non GxP System. Experience in GAMP5, GxP, EU Annex 11 and 21 CFR Part 11.Experience in creating Validation plan,IRA,FRA,FS/DS/CS, IQ,OQ,PQ,RTM,QSR Document. Experience in Functional Testing, System Testing, Integration Testing, User Acceptance Testing , Regression Testing.Experience in HP ALM Tools.Experience in data integrity principle.Experience in Electronic Data Management System by using Documentum for Life science Tool.Experience in Change Request by using ServiceNow Application.Experience in Veeva Vault, Veeva RIMS, Veeva QMS, Salesforce, Devops and Quality Document Management System (QDMS)

Computerized System Validation (CSV) of GxP IT systems , QC Software application ,SAP applicationGood knowledge of GAMP5, GxP, EU Annex 11 and USFDA 21 CFR Part 11,Good knowledge in data integrity principle.Document preparation (Author) and Review like initial protocols & reports for IQ, OQ, PQ & other validation deliverable(User requirement specification, Initial Risk Assessment, Validation Plan, Functional Risk Assessment, Functional Specification, Design Specification, Configuration Specification, Validation Report, Tractability Matrix, Summary reports etc.)

Computerized System Validation (CSV) of GxP IT systems.Good knowledge of GAMP5, Annex 11 and USFDA 21 CFR Part 11, Functional testing, CSV SOP including creation, review and approval of the electronic data system.Support all audit and compliance related activities to the IT system at the site.Document preparation and execution like initial protocols & reports for IQ, OQ, PQ & other validation deliverable(SRS, Gap Assessment, Risk Assessment, Validation Report, Tractability Matrix, Summary reports etc.)PLC and Excel Validation as per FDA and EU guidelines.

SDLC review for custom developed software IT application.Designing risk based validation approach for GxP system based on its category in GAMP 5Computerized system validation (GxP system) planning and execution Legacy system validation based on GAMP and EU requirements.Auditing of GxP IT system21 CFR part 11 Training &ImplementationData Integrity Training & Implementation.Electronic Data Management

Mathematics