Job Title

CSV ( Computer system validation ) Experience: 5 to 8 Years Location:- Bangalore Notice period : Immediate to 15daysRoles and Responsibilities of a CSV ConsultantUnderstand the clients current validation processes and perform activities accordinglyReview CSV deliverables to ensure system quality is not compromised and that systems are built in compliance with applicable regulations eg 21 CFR Part 11 820 210 211 EU Annex 11 etcAuthoring Review Approval Activities in ValGenesis VGSupport revisions to the Site Validation Plan SVP as requiredReview approve and guide revisions to User Requirement Specifications URS and Design Specifications DS divided by module where applicableSupport drafting of the Requirements Risk Assessment RRAReview and approve validation protocols in ValGenesis IQ SIT OQ UAT and PQReview and approve Data Migration ProtocolsAuthor Test PlansReview and approve Configuration Documents AMS Project in Adobe AcrobatExecution Validation SupportAssign preapproved protocols to the Local Deployment Team LDT Testers for execution as per environment requirementsPerform IQ promotion executions in QA and Production environmentsProvide preexecution training to ITLs and LDTs on document creation and execution in ValGenesis ensuring complianceGuide teams to minimize errors and suggest process improvements where applicableProvide validation execution support for QA phases as requiredPerform electronic execution in ValGenesis to confirm CSV verification post prerequisite executionException PostExecution ActivitiesGuide LDTsTesters in capturing protocol failures exceptions in ValGenesisTake ownership of exception assessment and closure in coordination with Catalent QAPerform postexecution review and approval of completed validation protocols in QA environmentsAuthoring of Summary ReportsCreate OQ PQ and Data Migration Summary ReportsCreate Validation Summary Reports VSRAuthor review and approve the Requirement Traceability Matrix RTM