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.

Keyskills: Automation ERP Change management Manager Quality Assurance SAP Agile Application development Life sciences HTTP SDLC
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