岗位职责：
1.Ensure that all QC Microbiology personnel are appropriately trained for their positions.

确保所有QC微生物人员都接受适当的岗位培训。

2.Prepare, review, implement and maintain QC Microbiology SOPs.

起草、审核、实施和维护QC微生物的SOP。

3.Develop, review, implement and maintain QC Microbiology test methods.

开发、审核、实施和维护QC微生物检验方法。

4.Undertake test method execution proficiency testing of QC Microbiology personnel.

承担QC微生物人员熟练按照检测方法进行测试。

5.As required participate in the Weekly Quality Organization Meeting.

按照需要参加每周质量部门会议。

6.As required participate in the Monthly Quality Organization and Operations Organization Meeting.

按照需要参加每月质量部门和运营部门会议。

7.As required participate in the Quarterly Management Review Meeting.

按照需要参加季度管理评审会议。

8.Undertake utility sample testing.

承担公用系统的样品检测。

9.Communicate utility testing data to the Manufacturing and Engineering Departments.

向生产部和工程部汇报公用系统的检验数据。

10.Maintain the utility testing records.

维护公用系统检测记录。

11.In conjunction with the Manufacturing Department undertake facility viable environmental monitoring.

与生产部协力承担设施的生产环境监控。

12.Communicate viable environmental monitoring data to the Manufacturing Department.

向生产部传达环境监测数据。

13.Maintain the viable environmental monitoring records.

维持环境监测记录。

14.In conjunction with Operations Department perform required testing to support equipment qualification / validation.

与运营部门合作执行必需的检测，为仪器的确认/验证提供支持。

15.Maintain the qualification / validation test records.

维护确认/验证测试记录。

16.Perform and report incoming API/material/component testing (bioburden/ endotoxin).

执行并报告来料API/物料/组分的测试（生物负荷/内毒素）。

17.Maintain API/material/component test records.

维护API/物料/组分的检测记录。

18.Perform and report in process testing.

执行并报告中间检测。

19.Maintain the in process test records.

维护中间检测记录。

20.Perform and report finished product testing (including sterility testing).

执行并报告成品检测（包括无菌检测）。

21.Maintain the finished product test records.

维护成品检测记录。

22.Perform the required QC Microbiology testing to support product stability studies.

执行需要的QC微生物检测，为产品稳定性研究提供支持。

23.Communicate the QC Microbiology stability test results to the QC Manager.

向QC经理报告QC微生物稳定性检测结果。

24.Maintain the QC Microbiology stability test records.

维护QC微生物稳定性检测记录。

25.Manage all QC Microbiology test samples (from sample point to post-test execution).

管理所有QC微生物检测样品（从取样到执行检测）。

26.Provide QC Microbiology services to support investigations.

提供QC微生物检测以支持调查

27.Provide QC Microbiology services to support product development.

提供QC微生物检测以支持产品开发。

28.Provide QC Microbiology services to support external customers.

提供QC微生物检测以支持外部客户。

29.Manage QC Microbiology services provided by contract laboratories.

管理由合同实验室提供的QC微生物检测。

30.Manage samples provided to / received from contract laboratories.

管理提供至合同实验室或来自合同实验室的样品。

31.Test method review and approval.

检测方法的审核和批准。

32.Maintain QC Microbiology log books.

维护QC微生物的检测台账。

33.Perform identification testing / classification of flora identified in the facility.

执行厂房设施中发现的植物的鉴别检测或分类。

34.Maintain the flora record for the facility.

维护厂房设施的植物检测记录。

35.Transfer QC Microbiology waste to the waste management area.

将QC微生物废弃物转移到废弃物管理区。

36.Responsible for drafting and revising microbiology control documents, including in-house specifications, sampling operation procedures, testing operation procedures.

负责微生物控制文件的起草和修订工作，包括内控质量标准、取样操作规程、检验操作规程。

37.Also responsible for the proper storage of standards, culture medias, and, samples.

负责标准品、培养基和样品的储存。

38.Responsible for microbe monitoring of clean room (area) to ensure the clean room (area) meets the pre-defined requirements of environmental monitoring.

负责洁净室（区）的微生物监测工作，保证洁净室（区）符合预定的环境监测要求。

39.Responsible for daily environment monitoring of dust particles and settling plates in the clean-room.

负责洁净室尘埃粒子和沉降菌的日常环境监测。

40.Responsible for the microbiology testing of pharmaceutical water and ensuring it complies with the pre-defined requirements.

负责制药用水的微生物检测，保证制药用水符合预定的要求。

41.Responsible for maintaining and using the precision instruments and equipment in the laboratory.

负责使用并维护实验室的精密仪器和设备。

42.Responsible for the coordination with Chemical laboratory for the calibration and maintenance of the laboratory equipment and instruments.

同化学实验室共同协调实验室设备和仪器的校准和维护。

43.Take part in the evaluation, audit and on-site inspection of supplier quality system.

参与质量体系内供应商的评估、审计及现场检查。

44.Responsible for investigating OOS and OOT results that occur in the lab.

负责调查实验室发生的OOS、OOT。

45.Take part in the investigation of quality complaints.

参与质量投诉的调查。

46.Take part in product annual quality review analysis, and provide supporting statistical data.

参与产品的年度质量回顾分析，提供支持性统计数据。

47.Take part in deviation investigation and change assessment which have direct impacts on product quality.

参与偏差调查和直接影响产品质量的变更评估。

48.Take part in product recalls.

参与产品召回。

49.Take part in investigation and handling of major quality accidents.

参与重大质量事故的调查处理。

50.Responsible for conducting on-the-job training to the department personnel.

负责部门内部人员进行在岗培训。

51.Responsible for determining the adequacy and qualification requirements of relevant personnel, instruments, meters and SOPs regarding contract analysis.

负责委托检验相关人员能力和资质要求、仪器仪表和SOP的确定。

52.Responsible for the monitoring of the stability/environmental chambers.

负责稳定性/房间环境的监控。

53.Complete any other work task assigned by QC manager.