Developing and implementing quality assurance policies and procedures.

Ensure compliance with GMP and ensuring the quality system is implemented in accordance with the latest regulations.

Ensure the fulfillment of GMP technical requirements or regulations of the BPOM related to the quality of the finished product.

Evaluating and giving approval to product stability data and other registration document data as well as managing other Pharmaceutical Industry License in accordance with the provisions of the Ministry of Health and BPOM of the Republic of Indonesia.

Evaluating and making decision to the result of deviation handling and change control.

Handling of drug complaint, reject product and drug recall.

Carry out duties as a responsible person of Pharmacovigilance in the company.

Release or reject finished product for selling by consider all related factors.

Coordinate and make sure implementation of calibration, qualification and validation program that conducted in the company.

Do the assessment for product quality in the product quality assessment of yearly program.

Initiate and participate in the internal and external audit implementation (audit to supplier, drug manufacturers and laboratories on a contract basis, Toll Out Partner).

Provide approval and conduct monitoring of materials suppliers, drug manufacturers and analysis based on contracts.

Coordinate and make sure the program implementation of personnel training in the company.