1.Establish microbiological laboratory management procedures, responsible for the daily lab management;
2.Establish aseptic test and microbial limit test methods and SOP to ensure that they meet the relevant requirements of ChP\EP\USP;
3.Effectively manage strains and culture media according to the approved documents, including the application, storage, subculture, use, and disposal of strains, and the application, storage, use, disposal and suitability test of the culture media;
4.Organize the daily analysis work of the microbiology laboratory, ensure the accuracy, timeliness and data integrity of all kinds of test and analysis data, and review and analyze test data regularly;
5.Report any abnormality to superior in time, and participate in the investigation of OOS/OOT and laboratory deviation;
6.Responsible for the maintenance of microbiological laboratory instruments, and to organize the verification and reverification of microbiological laboratory instruments, the validation, confirmation and transfer of microbiological analytical methods, assist in the validation of production processes and cleaning, participate in the validation of utility systems;
7.Responsible for the basic knowledge training related to microbiology;
8.Completed other tasks assigned by the company on time.
1.Undergraduate or above, major in microorganism/biology/medicine/life science, etc., at least 5 years experiences in microbiology and at least 2 years microbiological laboratory management experiences;
2.Good GMP awareness, familiar with ChP/EP/USP and GMP regulations, experience in FDA/EU inspection is preferred;
3.Have relevant analysis background, familiar with various microbial testing and analysis techniques, master microbial limit examination, aseptic examination, microbial strain identification, etc., can use and maintain microbiological laboratory equipment proficiently, and be able to process, judge and analyze the microbial testing data;
4.Teamwork spirit, strong logical thinking ability, quality awareness, safety awareness and good communication and coordination ability and execution;
5.Excellent Chinese and English reading and writing skills, proficient in office software, strong writing ability;
6.Experience in macromolecular drug laboratory construction is preferred.