Quality Lab Validation (CSV)

. Support validation and decommissioning activities for GMP laboratory systems and equipment

. Execute and review CSV deliverables including:

. Validation Plans

. Risk Assessments

. IQ/OQ documentation

. Traceability Matrices

. Summary Reports

. Assess impact of system retirement and data integrity requirements

. Support archival and migration activities for GMP data and electronic records

. Ensure compliance with GxP, 21 CFR Part 11, Annex 11, and internal quality procedures

. Work closely with QA, IT, Engineering, and Laboratory stakeholders

. Support change controls, deviations, and CAPA activities linked to system decommissioning

. Participate in shutdown planning and validation closeout activities