Job Purpose

To lead Quality Assurance operations for the Solid Oral facility and ensure compliance with cGMP, global regulatory requirements, data integrity standards, and Quality Management Systems.

Key Responsibilities

• Ensure compliance with cGMP, 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,...