Job information

　　1. Responsible for monitoring the whole process of entrusted production of drugs.

　　2. Regularly conduct quality audits on the entrusted enterprises, catch up with the rectification of audit defects, and evaluate the quality management system of the entrusted enterprises.

　　3. Responsible for the management and audit of suppliers of entrusted production of pharmaceutical materials.

　　4. Responsible for the review of batch production records and batch inspection records of commissioned drugs, and assist in the review of finished product release.

　　5. Responsible for reviewing the verification scheme, process regulations, batch production records, quality standards, etc. related to the entrusted production of drugs.

　　6. Responsible for organizing and handling deviations, changes, OOS, complaints, recalls, etc. that occur during the production process.

　　7. Assist in the review of entrusted production of pharmaceutical printing packaging materials.

　　8. Responsible for monitoring the verification status of equipment, facilities, and environment related to the entrusted production of drugs.

　　9. Assist the superior to complete the review and evaluation of the annual quality of commissioned pharmaceuticals.

　　10. Assist superiors to do a good job in MAH quality system construction and continuous improvement.

　　11. Assist superiors to complete the writing, revision and implementation of MAH quality system documents.

　　job requirements

　　1. Bachelor degree or above related to medicine, with professional knowledge of GMP, drug production supervision and management, etc.

　　2. More than 2 years of practical experience in drug production and quality management, with experience in drug on-site monitoring is preferred.

　　3. Familiar with the production process of oral solid preparations, experience in drug production license certification and compliance inspection is preferred.

　　4. Have strong communication skills and be able to adapt to business trips around Hefei.