Job Purpose
To lead Quality Assurance operations for the Solid Oral facility and ensure compliance with c GMP, global regulatory requirements, data integrity standards, and Quality Management Systems.
Key Responsibilities
- Ensure compliance with c GMP, Data Integrity, and global regulatory requirements including USFDA, WHO-GMP, EU GMP, MHRA, PIC/S, TGA, and ANVISA.
- Lead Quality Management System (QMS) activities including deviations, OOS, CAPA, change control, market complaints, and investigations.
- Oversee batch review, approval, and release activities.
- Ensure qualification and validation of processes, equipment, utilities, cleaning, and computerized systems.
- Manage vendor qualification, quality agreements, artwork approvals, and risk assessments.
- Lead internal audits, self-inspections, customer audits, and regulatory inspections.
- Coordinate with Production, QC, Warehouse, Engineering, Regulatory Affairs, and Tech Transfer teams for compliance an...