岗位职责:
Job purpose
职位目标
Be Responsible for the implementation of activities in Microbiology lab according to SOP
按照SOP要求，负责执行微生物实验室各项活动。

Main Responsibilities, Activities, Duties and Tasks
主要工作职责，活动和任务
? According to SOP ensure that the analysis and test meet the requirements of GMP regulations.
按照标准检验操作规程，确保各项分析测试符合GMP及法规要求。
? To follow the management requirements related to instruments, reagents, test solution, standard substance and reference substance, culture medium, bacterial species, samples and retention samples.
执行对检验用仪器、试剂、试液、标准品或对照品、培养基、菌种、样品及留样等的 管理要求。
? According to the requirements of standard operating procedures, responsible for testing and reviewing raw materials, intermediate products and finished products, to provide test report in a timely manner.
按标准操作程序要求，负责原材料，中间过程及成品的检测及审核，及时提供测试报 告。
? Establish/update the SOP if needed, ensure that the analysis and test meet the requirements of GMP regulations.
根据需要，建立/更新SOP，确保各项分析测试符合GMP及法规要求。
? Be responsible for Study stability of products.
负责产品的稳定性研究及测试。
? Be responsible for the environmental and water system monitoring of the classified area.
负责对工厂洁净区的环境和水系统监测。
? Be responsible for cleaning and disinfection of QC classified area.
负责QC洁净区的清洁和消毒
? Provide support for the transfer of instrument and test methods in the South Plant.
为南厂的仪器方法转移提供支持。
? Quality analysis and summary on a regular basis, report to the superior.
定期进行质量分析与总结，向上级 汇报工作。
? Aware of and comply with the corporate and local Quality/EHS Manual, Quality/EHS Management System, Quality/EHS Management Policy, Quality/EHS Goals, and applicable laws and regulations as they apply to this job type/position.
关注和遵守公司要求的质量、环境健康手册、管理体系和管理政策、目标和该职位的相关的法规要求。
? Implement the corresponding control measures strictly in accordance with the risk factors identified in the Job Safety Analysis.
按照工作安全分析的风险因素，严格执行相应的控制措施。
? Other work assigned by superior.
上级领导交代的其他工作。
任职要求:
College degree or above in Microbial, biological, pharmaceutical or related major.
大专或以上学历，微生物学、生物学、药学或相关专业

? Knowledge of GMP and drug administration regulations
对于GMP和药品管理有相关的专业知识；
? 3 years or above related working experience in laboratory, familiar with microbiological analysis.
3年或以上相关微生物分析的工作经验；
? Strictly comply with National laws and regulations, EHS and quality management system, abide by the company Code of Conduct, rules and regulations. Ensure that all work behavior conform to company's compliance requirements.
严格遵守国家法律法规，遵守EHS和质量管理体系规定，遵守公司员工行为准则和各项规章制度，确保所有的工作行为符合公司的合规要求。
? Microbiological/aseptic operation skills
微生物/无菌操作技能