Enterprise legal person refers to the enterprise (company) name, not a male or female natural person. The person in charge of the enterprise must be a natural person. So the enterprise legal person and the person in charge of the enterprise cannot be the same person.
The person in charge of quality, should be the top management of the enterprise, fully responsible for product quality management, independent performance of duties, within the enterprise product quality management has the right to rule. Enterprise quality should have a bachelor's degree or above, licensed pharmacist qualification and more than 3 years of experience in quality management of pharmaceutical business, quality management in the work of the ability to correctly judge and ensure the implementation.
Main responsibilities of the person in charge of quality management
1. Ensure that raw and auxiliary materials, packaging materials, intermediate products, products to be packaged and finished products comply with the requirements and quality standards approved by the registry;
2. Ensure that the review of the batch records are completed before the release of the product;
3. Ensure the completion of all necessary Approve quality standards, sampling methods, testing methods and other quality control procedures;
5. Review and approve all quality related changes;
6. Ensure that all significant deviations and exceedances of test results have been investigated and dealt with in a timely manner;
7. Approve and supervise commissioned tests;
8. Supervise the maintenance of plant and equipment to keep them in good operating condition;
9. Ensure that all necessary confirmations or verifications are completed, and review and approve confirmations or verification programs and reports;
10. Ensure that self-inspections are completed;
11. Evaluate and approve material suppliers;
12. Ensure that all complaints relating to product quality are investigated and dealt with promptly and correctly;
13. Ensure that all complaints related to product quality have been investigated and handled correctly and in a timely manner;
13. Ensure that the continuous stability inspection program of the product is completed, and provide data for the stability inspection;
14. Ensure that the product quality review analysis is completed;
15. Ensure that the quality control and quality assurance personnel have undergone the necessary pre-service and continuous training, and to adjust the training according to the actual needs. Adjust the content of the training according to actual needs.