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What I do
- Design risk-based CSV strategies and life-cycle documentation (e.g., URS, Risk Assessment, IQ/OQ/PQ/UAT, testing, traceability, reporting, archiving)
- Validate systems to ensure GxP compliance, including cloud, robotics, and AI-enabled solutions
- Oversee large-scale, cross-functional validation programs and manage global teams
- Establish scalable release and change management processes
- Act as a representative during audits/inspections and contribute to PV System Master File content
- Develop Standard Operating Procedures (SOPs) for CSV
- Provide expertise in regulatory and industry standards (e.g. FDA, EMA, MHRA, PMDA and GAMP®)
- Mentor teams to enhance their understanding and acceptance of CSV practices
