1.                  To assist the head department in establishment of the quality management system and to ensure compliance with GMP ASEAN and ISO 9001:2015, and applicable to the mission of the operation.

2.                  To maintain the quality system documents and implement on day to day the quality system at all levels of the organization

3.                  To prepare the SOP and other document including amendments.

4.                  To execute the internal quality audits for compliance to policies and procedures on paper vs practice and report on the performance of the quality system

5.                  To assist in investigation and ensure root cause is eliminated for production and control record errors, discrepancies, and failure to meet specification, including quality attributes.

6.                  To monitor all corrective and preventive actions are carried out timely and effectively and the Non-Conformance Report (NCR) are closed out.

7.                  Review the batch manufacturing record before the product are distribute/sale.

8.                  To ensure that procedures and specifications are appropriate and followed.

9.                  To execute the required initial and continuing training of the department personnel is carried out and adapted according to need

10.              To conduct inspections, ensure responses are complete, report the inspection and managed to verifiable closure.

11.              To understand company quality policy, relevant objectives, contribution to effectiveness of QMS, benefits of QMS, benefits of improved performance, and implications of deviating from the requirements.

12.              To implement all policies, activities, procedure, instruction as relevant and required by the QMS.

13.              To carry out any other duties as instructed by the Head of Quality Assurance Department and Head of Regulatory Division.