根据要求，GMP和相关药典要求来建立，更新和执行微生物检测和环境监控程序。并且参与验证，风险评估和偏差调查等活动。
Build, develop, and perform the microbial test and environmental monitoring program per requirements, GMP and pharmacopeia requirement. Participate in validation, risk assessment, deviation handling, etc.
1.负责分析方法验证，转移和确认
Responsible for method validation, transfer and verification.
2.起草检验操作规程以及实验室有关的SOP
Prepare test methods and SOPs related to QC laboratory
3.根据相关的SOP或标准测试方法执行日常必须的测试
Perform the necessary tests according to the relevant SOP/Test Methods
4.执行环境监测和常规的公用系统的检测
Perform routine environmental monitoring in clean room and test the clean utility system
5.严格执行实验和实验结果记录
Document the tests and results in the associated system
6.执行微生物实验室试剂以及菌种、培养基、细菌内毒素检查用品的管理
Perform management of reagents, and cultures, mediums, articles for bacterial endotoxin test in microbiology laboratory
7.执行稳定性试验的微生物测试
Perform microbial test of stability study
8.按照计划完成水系统取样的工作。
Complete sampling of water system according to the plan.
9.执行实验室的偏差、OOX结果调查，执行CAPA
Perform investigation of deviation and OOX results, as well as CAPAs within microbial lab
10.如需要，培训检验人员
Provide training to other analysts if required
11.执行微生物实验室设备，方法或其他系统的验证和再验证
Perform the validation and/or revalidation activities for the Microlab equipment, test methods or any other system.
12.执行或协调微生物室内仪器的校验活动
Perform or coordinate the calibration activities for equipment in microbiological lab
13.相关文件的撰写，如实验方法，SOP，验证文件等
Prepare associated documents such as Test Method, SOP, validation protocol etc.
14.为其他部门人员提供微生物相关知识的培训
Provide microbiological knowledge to other departments.
15.承担个人安全职责，保护自己，并避免伤害他人和环境。
Take the EHS responsibility. Attend required EHS training and rehearsal
16.负责水系统的取样
Responsible for water system sampling
17.参加该岗位的必须的安全培训并配合应急预案的演练
Attend required EHS training and rehearsal
18.严格执行岗位安全操作规程。及时汇报工作中的任何事故事件和危险源
Strictly following EHS procedure. Report any EHS accident and hazard in a timely manner
职位要求：
大专或以上学历，药学，生物学专业
College or above degree in Pharmacy, Biology, etc
制药或相关行业3年以上微生物分析工作经验
3 years or more work experience as microbiologist roles in Pharmaceutical industry or associated industries.
?在制药领域具有综合的微生物知识，包括微生物测试，环境监控，验证等
Comprehensive knowledge of microbial testing, environmental monitoring, validation, etc. in Pharmaceutical industry
?了解制药行业的质量体系，GMP和药典的要求
Knowledge of Quality System, international GMP and Pharmacopeias in Pharmaceutical industry
能用英语读写，会熟练使用电脑
Read and write in English and good computer skil

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