- Plan, execute, and document validation activities, CAPA, OOS, Investigation, Vendor qualification, Deviation management.
- Perform process validation, cleaning validation, and equipment qualification.
- Prepare and review validation protocols, reports, and SOPs.
- Ensure compliance with GMP, GLP, and regulatory requirements.
- Coordinate with production, QC, and engineering teams for validation activities.
- Handle revalidation, change control, and risk assessment (QRM) and QMS, Monitor validation schedules and ensure timely completion.