Computer System Validation Engineer

2 days ago


Hyderabad, Telangana, India Velocis Full time ₹ 9,00,000 - ₹ 12,00,000 per year

The position provides an excellent opportunity to:


• Identify and manage regulatory risks to support client in regulatory compliance, governance and controls


• Coordinate with cross-functional project teams for new application development and other validation projects to include reviews, risk analysis and other QA activities in support of systems development


• Author validation strategies and other plans/protocols and summary reports (end-to-end computerized system validation experience is mandatory)


• Coordinate and interface with R&D, Engineering, Software Development, IT, Manufacturing and Quality Assurance groups to assure successful project execution and end-user training


• Plan, manage and execute as needed, installation, operational and performance qualifications in accordance with current Good Manufacturing Practices (cGMPs)


• Review and approve validation lifecycle documentation


• Provide Quality review and assessment of associated change requests related to processes, IT infrastructure and computer systems.

Must Have


• 2 to 6 years of experience in Computer systems validation.


• Validation experience in Agile SDLC.


• Working experience of tools like JIRA, HP ALM, Qtest, SAP, Solution manager, Servicenow , Valgenesis, Veeva etc.


• Working experience of processes like change Management, Periodic reviews, CAPA/Deviation management.



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