Responsibility

1. Establish the microbiological testing procedures and Execute the microbiology-associated analytical method validation.

实施微生物相关的分析方法验证。

2. Proactivilty participate the Aseptic Processing Validation (APV) and the Aseptic Operation Qualification (AOQ).

积极参与无菌工艺验证和无菌操作确认

3. Set up the procedures for isolating environment stressed microorganisms.

建立环境微生物的分离规程

4. Establish the identification procedure for the required microorganisms.

建立相关环境微生物的鉴定规程

5. Complete the microbiological testing including sterility test and bioburden test of utility monitoring, raw materials, intermediates, finished products and others samples within the lead time in accordance with applicable procedures, specifications, regulatory requirements (e.g. current Ch.P, GMP) and CBMG quality standards.

按照相应的规程、标准、法规要求（如现行版中国药典）和CBMG质量标准要求在检验周期内完成公用系统监测、原辅材料、中间品和产品的无菌、微生物限度等微生物学检验。

6. Ensure all the quality control procedures and specifications related to microbiology testing are established, periodically reviewed and maintained in compliance with regulatory requirements and CBMG quality standards.

确保微生物学检验相关的质控程序和质量标准均按照法规要求和CBMG质量标准要求进行建立、定期回顾和维护。

7. Ensure no shorten of consumables and reference standards used in QC lab, e.g. co-ordinate the purchasing, periodic checking, and applying reagents from warehouse.

确保检测用耗材、标准品无短缺问题发生，如协调采购、定期确认和及时领料等。

8. Review the records issued by other analyst to ensure testing has been performed per applicable requirements, and results have been properly reported.

审核其他分析员的检验记录，确保检验过程符合相应的要求并被准确地报告。

9. Report any atypical or out of specification/trend/expectation test result and participate in the investigation. Timely and effective communicate and escalate of quality issues to the appropriate levels of management.

• 异常或超标/趋势/期望的检验结果，并参与调查。确保及时有效沟通质量问题并上报至合适的管理层。

10. Train new analysts and production personnel according to the site SOP.

按照相关规程要求培训新的分析员和生产人员。

11. Support and co-ordinate the validation, calibration and maintenance of equipment in QC lab.

支持和协调实验室设备的验证、校验及维保工作。

12. Support the activities related to classified area, including clean and disinfectant, environmental monitoring, etc., to ensure no impact on the testing.

支持洁净室的相关活动，包括清洁消毒、环境监测等，确保不影响日常检验。

13. Analyze the environmental microbial trend of EM results every month and give Suggestions for improvement.

每月分析环境检测数据的环境微生物趋势并给出改善意见。

14. Cooperate with the manufacture team and equipment team, establish the new plant environment monitoring site and establish the new plant environment monitoring process, and build the SOP.

配合生产团队及设备部伙伴，建立新厂房环境监控位点及建立新厂房环境监控流程和SOP。

15. Perform the bacteria endotoxin and Gram's stain testing.

• 细菌内毒素检查和革兰氏染色的检测工作。

16. Perform the sampling and testing of liquid nitrogen, CA and CO2.

• 液氮、压缩空气、二氧化碳取样检测工作。

17. Perform the environmental monitoring activities, including particulate, active air, settle plate, surface monitoring and personnel monitoring.

• 日常环境监控的工作（悬浮粒子、浮游菌、沉降菌、表面微生物及人员监控）。

18. Assure adherence to all safety and health policies and procedures.

确保遵守所有的安全和卫生政策和程序。

19. Perform other duties as requested.

按要求履行其他职责。

Requirement

1. Bachelor or above in food science, biology related majors（Bachelor degree, more than 3 years relevant work experience required; Master degree, more than 2 years relevant work experience required.

2. 大学及以上学历，食品科学，生物相关专业 (大学学历，3年以上相关工作经验；硕士及以上学历，2年以上相关工作经验。

)。

3. Knowledge and experience with environmental monitoring and qualification of GMP cleaning rooms.

具有GMP环境监测和确认经验。

4. Knowledge with microbiology identification and analysis

有微生物分析检定经验

5. Experienced with EM trend analysis and drafting of review report

有环境监测趋势分析及定期回顾分析经验

6. Strong professional ability with microbiology operation.

独立熟练地微生物操作技能。

7. Good written and verbal communication skills. Fluent in Mandarin, proficient in English is preferred.

良好的书面和口头沟通能力。流利的普通话，熟练的英语。

8. Experience with Microsoft Office Suite, i.e. Word, Excel, PowerPoint, Outlook, etc.

有微软办公软件的经验，如Word、Excel、PowerPoint、Outlook等。

9. Good organization skills and a strong ability to take direction from multiple sources.

良好的组织能力和较强的能力，能从多个来源获得方向。

10. Knowledge and experience with laboratory QA/QC plans and procedures.

有实验室质量管理计划和程序的知识和经验。

• Honest, responsible and team working

为人诚恳，有责任心和有团队精神

上班地址：浦东新区张江高科技园区法拉第路85号