Yusri Yusoff

1. Ensure Bangi 1, Bangi 2 and Bangi 3 premises and its operation complies with current GMP (cGMP & GDP) guidelines as defined by local drug control authority. 2. Documentation Control: Ensure proper control and maintenance of all QA documentation related to GMP, ISO 9001, GDPMD, TGA & EU. 3. SOPs: Ensure that all SOPs are generated, maintained, distributed and reviewed according to the GMP, ISO 9001, GDPMD, TGA & EU requirements. 4. To carry out investigation on product complaint, NCR, DEV, CAPA and ensure closure. 5. Cooperate with all departments to ensure that all critical measuring and testing equipment / instruments (M&TE) use in the manufacture and testing of products are appropriately calibrated and documented for reference. 6. The Members to ISO 9001 have the following responsibilities: i. To establish departmental processes (procedures, work instructions and forms). Ii. To ensure departmental processes are implemented and maintained. Iii. To report to MR on the performance of departmental processes and any need for improvement. Iv. To ensure awareness of the organization quality policy and quality objectives among department staff. 7. To perform walkabout as per schedule and ensure compliance with current GMP (cGMP & GDP) guidelines as defined by local drug control authority. 8. Return Product: to check, evaluate and verify returned products to the finished goods warehouse for resale, repacking or rejected.