CSV ( Computer system validation )

CSV ( Computer system validation )

Experience: 5 to 8 Years

Location:- Bangalore

Notice period : Immediate to 15days

Roles and Responsibilities of a CSV Consultant

• Understand the clients current validation processes and perform activities accordingly
• Review 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 etc
• Authoring Review Approval Activities in ValGenesis VG
• Support revisions to the Site Validation Plan SVP as required
• Review approve and guide revisions to User Requirement Specifications URS and Design Specifications DS divided by module where applicable
• Support drafting of the Requirements Risk Assessment RRA
• Review and approve validation protocols in ValGenesis IQ SIT OQ UAT and PQ
• Review and approve Data Migration Protocols
• Author Test Plans
• Review and approve Configuration Documents AMS Project in Adobe Acrobat
• Execution Validation Support
• Assign preapproved protocols to the Local Deployment Team LDT Testers for execution as per environment requirements
• Perform IQ promotion executions in QA and Production environments
• Provide preexecution training to ITLs and LDTs on document creation and execution in ValGenesis ensuring compliance
• Guide teams to minimize errors and suggest process improvements where applicable
• Provide validation execution support for QA phases as required
• Perform electronic execution in ValGenesis to confirm CSV verification post prerequisite execution
• Exception PostExecution Activities
• Guide LDTsTesters in capturing protocol failures exceptions in ValGenesis
• Take ownership of exception assessment and closure in coordination with Catalent QA
• Perform postexecution review and approval of completed validation protocols in QA environments
• Authoring of Summary Reports
• Create OQ PQ and Data Migration Summary Reports
• Create Validation Summary Reports VSR
• Author review and approve the Requirement Traceability Matrix RTM