Developer

• Very good knowledge on reviewing IQ, OQ, PQ and PIQ Protocols and executions of same
• Very good knowledge on Valgenesis, JIRA and Solution Manager tool
• Active participation in Requirement Risk Assessment Calls
• Creating and Reviewing Validation Plan and Validation Summary Report
• Very good knowledge in SDLC & STLC concepts
• Having extensive experience working with world's leading Pharma giants
• Having good experience in Pharmaceutical / Life Sciences / Clinical Trial Domain
• Experience on working according to 21 CFR Part 11, FDA & GAMP guidelines
• Good Knowledge in writing and Executing Test Cases in Valgenesis tool
• Coordinating with the Development team for bug fixing and on time Project Delivery
• Review deliverables at each defined timeline to authorize project to next phase
• Good knowledge on Azure Dash board
• Knowledge on planning the release timelines.
• Coordinating with the Development team for bug fixing and on time Project Delivery

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