- Lead and support GxP validation activities for software applications, platforms, and digital products.
- Develop and maintain validation deliverables, including Validation Plans, Risk Assessments, IQ/OQ/PQ protocols, Traceability Matrices, and Validation Summary Reports.
- Collaborate with development, QA, DevOps, and business stakeholders to ensure compliance throughout the SDLC.
- Review system requirements, functional specifications, design documents, and test evidence for regulatory compliance.
- Support Computer System Validation (CSV) activities aligned with GxP, FDA 21 CFR Part 11, Annex 11, and applicable industry standards.
- Perform risk-based validation assessments and identify compliance gaps.
- Participate in audits, inspections, and quality reviews, providing validation evidence and documentation.
- Ensure change controls, releases, and system enhancements maintain validated status.
- Drive continuous improvement of validation processes and compliance practices.