工作内容
• Define topics used in testing raw materials. Packing material Products waiting to be packed and ready-made medicine Both chemically and microbiologically Ensure all necessary testing is carried out. for good product quality• Ensure sampling requirements and methods. Methods for testing raw materials, packaging materials, products waiting to be packed. and ready-made medicine• Evaluate inspection records. Analysis Consider evaluating the data obtained from the test. Ensure that the test results pass the requirements.• Certify the results of inspection of raw materials, packing materials, products waiting to be packed. and ready-made medicine Through the testing process according to the requirements of raw materials, packaging materials, products waiting to be packed. and ready-made medicine• Review the analytical documents in the Quality Control Department to certify that the quality of the product is correct according to the drug registration and then release the product for sale.• Verify results and monitor analytical contractors. As detailed in the analysis contract In case of hiring an outside laboratory• Check the recording of raw data. Record the use of analytical tools Record the controlled conditions in the quality control department• Create a study protocol. Conducting a study and report the results of the study of product stability.• Manage collection or reference samples.• Collect product samples and conduct inspections/investigations/tests to find out the facts. When a complaint occurs or request from the FDA or customers• Manage chemicals, standard substances, equipment and testing analytical tools. To be always ready to use• Check cleanliness. Maintenance of work sites, both in the laboratory and other operational support areas.• Train the team to ensure that the personnel in the quality control department have the ability to perform their duties and responsibilities.• Carry out verification of analytical method accuracy (Analytical Method Validation) and suitability of test methods (Method Suitability Test).