About the role
- Strong knowledge of GxP regulations, FDA requirements, and industry compliance standards governing validated systems.
- Proven experience in preparing, reviewing, and approving validation deliverables, including Validation Plans, Risk Assessments, URS, FS, Traceability Matrix, Test Scripts, IQ/OQ/PQ, SIT, UAT, and Validation Summary Reports.
- Expertise in ensuring regulatory compliance, audit readiness, data integrity, and system validation throughout the project lifecycle.
- Capable of supporting validation strategy, testing execution, compliance reviews, defect management, document signoffs, go-live readiness, and hyper care support for SAP implementations in a regulated environment.
BenefitsContract
Period: 6-12 months
Location: Work from Office Ahmedabad