执行原辅料、包装材料、中间产品的取样
Raw materials, excipients and intermediate sampling
执行日常微生物相关的检验，包括微生物限度检查、细菌内毒素检查及无菌检查等
Perform routine microbial related analysis, including microbial limit test, endotoxin test and sterility test
水系统及洁净环境的日常监控
Water system and clean environment monitoring
培养基、菌悬液及其他实验相关试剂的制备
Preparation of culture media, buffer solution and microbial strain for testing
协助OOS/OOT/偏差的调查
Asist OOS/OOT/Non-compliance investigation
工作要求Job Requirement ?
大专及以上学历，药学，微生物学或生物技术相关专业 College or above degree in Pharmacy, Microbial, Biotechnical, ? 了解中国药典、美国药典、欧洲药典及GMP/cGMP/欧盟GMP的相关要求 Understand the ChP/USP/EP and theGMP/cGMP/EU GMP ?
熟悉无菌检查、微生物限度检查、细菌内毒素检查等药品微生物的检测及方法验证 Familiar with the sterility test/microbiology limit test/endotoxin test and also the TMV ?
熟练掌握细菌内毒素检测仪器、无菌检查隔离器、脉动真空灭菌柜、微生物鉴定仪等常用设备的使用 Familiar with the usage of common equipment such as endotoxin testing equipment, isolator, autoclave, ID detector, etc.
医药行业1年以上微生物实验室工作经验 1 years working experience in pharmaceutical Micro-lab
英语水平良好，熟练使用Office软件 Good English，and familiar with Office software
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