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QA supervisor

Job responsibilities:

1. Responsible for organizing the formulation of the company's quality management system and the audit of relevant GMP documents, and preparing the audit work.

2. Organize and implement the quality control of R&D and pilot process.

3. Responsible for the IQ/OQ and daily calibration of the core process equipment;

4. Organize and implement the inspection work on the retention samples and stability of QC's main materials and products;

5. Arrange deviation, change control and other investigation and audit according to the regulations, and propose and track the implementation of CAPA.

6. Assist the quality director in the implementation of GMP training, and coordinated the work relationship between the department and other departments;

7. Participate in supplier quality audit and product quality review.

QA specialist

Job responsibilities:

1. Responsible for the management of quality files, and responsible for the management of GMP files;

2. Supervise and check the original records (including relevant records of equipment and equipment), batch records, reports and retention samples, and verify the integrity and authenticity of the data;

3. Organize and coordinate the preparation, revision and audit of GMP documents; Responsible for the release and implementation of GMP documents;

4. Conduct inspection and inspection on the implementation of GMP in all departments, and conduct follow-up and analysis on quality issues;

5. Assist the purchasing department in the material supplier assessment, and established the list of qualified suppliers and the supplier files;