职位描述
POSITION SUMMARY（职位概述）
Plan and conduct micro analysis/test and documentation required by control plan/SOPs for raw materials, finished product, utilities, environmental and other necessary. Take main responsibility for micro analysis relevant implemented to meet corporate/ISO/GB/regulation/GMP requirements.
计划、执行微生物实验室分析和测试，包括原料、成品、公用设施、环境和其他必要的测试。确保相关微生物分析测试符合公司/ISO/GB/法规/GMP的要求。
KEY RESPONSIBILITIES（主要职责）
1. Set up the management rules to ensure the efficiency of laboratory work under the well compliance with the corporate/ISO/GB/regulation/GMP requirements.
建立微生物实验室管理规程确保实验室的有效运行，并符合公司/ISO/GB/法规/GMP的要求。
2. Perform qualification/validation/calibration and maintenance for analytical devices to ensure analytical devices in good status and GMP compliance.
执行分析设备/仪器的确认/验证/校验和维护以确保分析设备/仪器处于良好的状态和GMP的符合性。
3. Plan and execute the microbiological limits test/sterility test/Endotoxin test method validation.
计划和执行完成微生物限度检查、无菌检验、细菌内毒素测试的方法验证。
4. Perform and record microbiological testing for raw material, packaging material, products, stability, utilities, environmental sample by following Quality Specification /control plan, to provide accurate testing results on time
依据质量标准/检验计划完成原料、包装材料、产品、稳定性、公用设施、环境等的微生物测试，并及时提供准确的检验数据。
5. Handle chemical reagents, biological reference substances/standard strains and solutions appropriate to compliance with the regulations and SOPs, to keep safe and tidiness of working area.
依据法规和SOPs要求操作化学品、微生物参考物质/标准菌株、溶液等，确保实验室安全和工作区域的整洁。
6. Cope with abnormities of the testing in time by reporting to the supervisor, or appropriate to the instruction of SOP.
及时调查实验室测试异常结果的调查。
7. Leading and working on OOS investigation for microbial results of water/raw material, products.
领导水、原料、产品微生物检验的任何OOS的调查活动。
8. As a microbiological expert provide training to production, involve in relevant deviation investigation.
作为微生物专家给生产部提供相关微生物培训、参与相关偏差调查。
9. Perform the annual products sterilization validation and report all the validation testing.
参与产品的年度灭菌确认并负责产品验证时实验的组织和结果的控制;
10. Plan and reviewing the inventory of reagent, glassware and miscellaneous items in microbiological laboratory and make order plans based on the budgets.
计划微生物实验室试剂、玻璃仪器、耗材的采购和维护适当的库存管理。
11. Other work need to do.
任何其他安排的工作。
SKILLS AND ABILITIES（技能）
1. Above bachelor degree of microbiological, or relevant.
微生物或相关专业，本科或以上学历毕业；
2. 3 years’ experience for micro analysis.
相关微生物工作经验3年以上；
3. GMP/ISO13485 knowledge as basic for the role
具备GMP/ISO 13485相关知识
4. Good communicate and learning skill.
良好的沟通技巧、学习能力；
5. Skill of Microsoft office .
电脑办公软件应用熟练；
6. Skill of English in reading and writing.
有一定的英语读写能力。
7. With or be trained Pressure Vessel Operation Certificate preferred
持有压力容器操作证，或经相关培训
