Posted:1 day ago|
Platform:
Hybrid
Full Time
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.
Velocis
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