- Provide QA oversight and support for automation-related qualification and validation activities
- Review and approve validation lifecycle documentation (IQ/OQ/PQ protocols, reports, risk assessments, traceability matrices, change controls, deviations, and CAPAs)
- Support automation systems operating within GMP manufacturing environments
- Ensure compliance with FDA, cGMP, GAMP 5, and 21 CFR Part 11 requirements
- Partner with Automation, CQV, CSV, Manufacturing, and Quality teams
- Participate in document reviews, project meetings, and quality assessments
- Support audit readiness and inspection preparedness activities
- Assist with implementation and continuous improvement of validation and QA processes