Quality Assurance Manager

Địa Điểm Làm Việc: Bà Rịa - Vũng Tàu
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Mức độ phù hợp công việc - Xem chi tiết

Các Phúc Lợi Dành Cho Bạn

Salary negotiable.
Full welfare regimes according to state regulations:social insurance,health insurance, ...
Periodic health examination

Mô Tả Công Việc

• Participate in building, implementing and controlling the system of standard operating procedures (SOPs), standards, instructions, regulations... of the quality assurance department in compliance with GMP-WHO regulations. Ensure processes are reviewed periodically.
• Responsible for preparing and ensuring full implementation of regulations to achieve good results in GMP re-evaluations.
• Develop original assessment plans programs and program and organize activities to carry out internal assessment, inspection, and self-inspection activities of the factory on production processes, maintenance processes, and equipment cleaning, equipment, auxiliary systems (HVAC, RO water, distilled water, compressed air... )…
• Periodically monitor controlling the environment, water, and compressed air.
• Monitor controlling calibration, inspection, maintenance of equipment, auxiliary systems, fire protection...
• Develop and implement training plans for factory employees on GMP (basic and advanced), external training, manage training programs of other departments.
• Coordinate with departments to build, implement, and contribute to improving cleaning, production, maintenance processes, and SOPs related to the quality system and products in the company.
• Monitor the management of the entire system of GMP documents and records.
• Participate in supplier evaluation with the QC department. Check the test report of raw materials (used for production and import-export), packaging, finished products and sign to approve storage or discard. Label incoming materials with acceptance or rejection status.
• Monitor the drug production process throughout from the time of importing raw materials for production, packaging to the finished product.
• Monitor the control of production conditions (temperature, humidity, pressure, cleanliness...) and check during production.
• Evaluate the entire production process (product batch records, test result sheets, results of assessment of production conditions, inspection during the production process...).
• Review and sign off on batch records and finished product release orders, standard operating procedures, test reports, protocols, appraisal/evaluation reports, and other specialized documents of the System quality, such as Quality Manual, Overall Appraisal Plan...
• Check the establishment and maintenance of batch records.
• Monitor quarantine and preservation (raw materials for production and import/export, packaging, intermediate products, products awaiting packaging, finished products.)
• Monitor product stability testing.
• Responsible for resolving complaints, returned goods, and product recalls.
• Monitor the application of the code system on equipment, raw materials used for production and import-export, packaging, and finished products.
• Report monthly to the Factory Director and Board of Directors on the situation and results of assigned work
• Continuously update new (related) circulars and decrees of the Ministry of Health and update SOP & implementation.
• Perform other tasks assigned by the Factory Director or requested by the Board of Directors.
Compliance Responsibilities:
• Responsible to the Board of Directors and the company for the implementation of the drug factory regulation system
• Quality policy and instructions on good practices of GMP, GLP, GSP in the Company.
• Propose opinions to the Head of Department and Board of Directors on issues related to the quality system.
Xem toàn bộ Mô Tả Công Việc

Yêu Cầu Công Việc

• Graduated from University majoring in Pharmacy
• At least 3-5 years of experience in QA used to work in pharmaceutical companies. Priority will be given to candidates who have worked in the same position.
• Experience in building and managing quality systems according to GMP-WHO. Have experience in GMP approval of Pharmaceutical factories
• Foreign language proficiency: English (good at reading and translating specialized documents)
• Priority is given to having relevant certificates.
• Have teamwork and situation handling skills.
• Serious, careful, honest attitude.
• Salary negotiable.
• Full welfare regimes according to state regulations: social insurance, health insurance, unemployment insurance.
• Periodic health examination

Địa Điểm Làm Việc

My Xuan Town, Ba Ria Vung Tau

The position is based in My Xuan Town, Ba Ria Vung Tau. You will work at Leung Kai Fook manufacturer of a 100% capital of Singapore company which is over 20 years in Vietnam. We are having Axe brand Oil and inhalers, a Singapore heritage brand oil with more than 90 years experiences.

Xem toàn bộ thông tin công ty
39B Truong Son, Ward 4, Tan Binh District, Ho Chi Minh City.
25-99 nhân viên
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