Key Responsibilities:
• Manage the site’s deviation system, ensuring timely investigation, root cause analysis, and closure of quality events.
• Oversee change control activities, ensuring all changes are properly assessed, approved, and implemented in compliance with GMP requirements.
• Coordinate and review annual Product Quality Reviews (PQRs), analyze quality trends, and support continuous improvement initiatives.
• Manage internal audits, support regulatory and customer inspections, and ensure timely closure of audit observations.
• Review, monitor, and verify the effectiveness of CAPAs resulting from deviations, audits, complaints, and quality reviews.
• Monitor quality compliance KPIs and prepare periodic reports for management.
• Ensure GMP compliance across site operations and support inspection readiness activities.
• Coach and support team members while promoting a strong quality culture across the site.