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1、Responsible for the validation and daily monitoring of HVAC, process water, and process gas systems in the pro-port plant and laboratory.
2、Responsible for the confirmation or validation of microbiology laboratory testing methods, including but not limited to microbial limit, sterility, and bacterial endotoxin testing.
3、Responsible for microbial limit, sterility, and bacterial endotoxin testing of raw and auxiliary materials, packaging materials, central control products, and finished products.
4、Responsible for drafting or revising microbiological testing related SOPs, MOPs, protocols and reports.
5、Report deviations, AD/OOS/OOT issues in the testing process to supervisors in a timely manner and complete related investigations.
6、Ensure that daily behavior and operations can fully comply with GMP requirements.
7、Complete other tasks assigned by the supervisor.
1、Specialist or above in microbiology, biology, pharmacy or other related majors.
2、master the basic principles of testing experiments; familiar with drug GMP specifications.
3、Good English reading ability and proficiency in computer operation.
4、Relevant experience is preferred.