Description
> Must Have Skills• Hands On experience of CSV implementation with involvement in Installation/Operation Qualification/Performance Qualification, protocol development/writing & execution in GxP environment
• Experience of Infrastructure Qualification, Data Centre Qualification, Data Centre migration.
• Good understanding /exposure to FDA regulations /Global healthcare regulations for Pharma, Regulatory Compliance , CFR Part 11 Compliance, EU guidelines, alignment to GAMP5
• Experience of creating and executing infrastructure qualification protocols
> Good to Have skills
• Test Management, Automation, HP ALM Experience
> Working experience
• Experienced/Good understanding of SDLC and GAMP5 Guidance
• Experience of Data Centre and Infrastructure Qualification
• Experience of Data Migration Validation
• Validation test scripts creation and execution
• Deployment of applications in a validated state
• Closely working with the application team to ensure systems are in validated state.