岗位职责：



洁净区的日常环境监测和维护；

负责产品微生物限度、无菌、细菌内毒素检查的方法确认和检测；

负责原辅料、工艺用水、工艺用气的微生物检测；

负责培养基适用性试验、生物指示剂芽孢计数；

负责菌种的分离、纯化、保存与使用；

负责责任范围内的文件起草；

微生物检验设备的日常维护；

完成上级安排的其他相关工作。




任职资格：



***大学本科及以上学历，药学、生物工程等相关专业；

两年以上制药企业微生物实验室相关工作经验；

熟练使用办公软件；

能阅读USP、EP等国外药典和英文文献；

良好的团队协作能力；

工作细致、富有责任心，善于发现问题、解决问题，具有较强的学习能力。







Responsibility：



Environmental monitoring and maintenance in clean areas.

Responsible for the analytical method validation of Microbial limit, Sterility tests, Bacterial endotoxins test, and routine testing.

Responsible for microbial monitoring of raw materials, process water and process gas.

Responsible for medium suitability test, biological indicator spore count.

Responsible for isolation, purification, preservation and use of strains.

Responsible for documentation within the scope of responsibility.

Daily maintenance of microbiological equipment.

Other tasks assigned by the supervisor.




Qualification:



Bachelor degree or above, major in pharmacy, biological engineering, etc.

At least 2 years experience in microbiology lab in pharmaceutical company.

Familiar with office software;

Can read USP, EP and other foreign pharmacopoeia and English literature;

Good teamwork ability.

Working carefully, responsible, good at finding and solving problems, with strong learning ability.