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System QA Team leader
Work location
Room A708, Building 1, No.600 Huaxi Road, Minhang District, Shanghai
Job type
Management position
Job responsibilities
1. Responsible for the management, drafting and revision of GMP documents and the review of other documents.
2. Review pre-release inspection records and batch production records of materials, intermediate products and finished products to ensure that the records are filled in timely according to standard requirements, and the content is comprehensive, true and effective.
3. Supervise the implementation of unqualified materials, intermediate products and finished products.
4, responsible for the investigation and treatment of deviations, responsible for the implementation of change tracking. Supervise the implementation of corrective and preventive measures.
5. Responsible for the investigation and handling of user visits and user complaints.
6. Participate in product recall, organize and supervise the destruction of returned and recalled drugs due to quality reasons.
7, responsible for drug production license change data sorting and declaration.
8. Cooperate with the completion of the company's GMP self-test.
9. Responsible for the evaluation and audit of the quality system of major material suppliers.
10. Organize personnel to complete annual review analysis.
11. Cooperate with the company's relevant domestic GMP certification and FDA certification to ensure the smooth passage of the company's certification.
Qualification
1, college degree or above, pharmacy related major.
2. More than 3 years working experience in drug production and quality control. Familiar with the relevant laws and regulations of drug production and quality management, and have practical work experience in quality system management.
3, familiar with regulations, including but not limited to Chinese pharmacopoeia, GMP regulations, understanding of foreign regulations is preferred.