QA Manager

Responsibilities:

1. According to GMP and relevant laws, regulations and guiding principles, establish and improve the MAH quality management system documents and operating procedures, supervise the implementation and continuous improvement, and ensure that the document system and workflow meet the specification requirements;

2. According to national statutory standards, industrial standards and product characteristics, formulate internal quality control standards for materials, intermediate products, finished products and other products to ensure the stable and qualified quality of listed products;

3. Organize and complete the self-inspection of the MAH system and the regular audit of the entrusted production, and cooperate with the drug supervision department to complete the GMP compliance inspection and product sampling inspection;

4. Organize the quality monitoring and information communication of the entrusted products, and timely find and solve the quality problems related to the products;

5. Manage the quality agreement, deviation, change, OOS and CAPA of the entrusted products, participate in the investigation, analysis and evaluation, formulate the implementation measures, and supervise the implementation;

6. Organize the investigation of quality complaints, adverse reactions, returns and recalls, track the processing progress, and complete the investigation report;

7. Cooperate and participate in key activities in product development, process validation and technology transfer, and organize risk management activities such as co-production;

8. Manage suppliers, participate in supplier selection, qualification review, on-site audit and other activities, establish and dynamically maintain supplier quality files;

Job requirements:

1. Familiar with GMP and relevant regulations and guiding principles of the domestic and foreign drug industry, and have a deep understanding and application;

2. At least 5 years of quality management experience in large MAH, and at least 2 years of team management experience;

3. At least be familiar with the process, standards and relevant specifications of oral solid preparations.