
Computer System Validation Engineer
2 days ago
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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