Oversee the Quality Management System (QMS) and ensure strict compliance with GMP standards and regulatory requirements.
Maintain the quality system and lead both internal and external audits.
Monitor end-to-end product quality throughout the entire manufacturing process.
Draft, review, and approve quality-related documentation and files.
Manage customer complaints and conduct supplier quality audits.
Analyze quality data statistics and compile Annual Product Quality Reviews (APQR).
Review production records, manage changes and deviations, oversee retention samples, and supervise validation activities.
Exercise authority to supervise and halt the use or distribution of non-conforming products, raw materials, and packaging materials.
Organize and deliver quality awareness training to ensure staff compliance.