工作职责:

？ 负责微生物检测方法验证/确认，以确保检测方法符合辉瑞PQS和法规要求。

Responsible for microbial method validation/verification to make sure the test methods be in compliance with regulatory and Pfizer PQS requirements.

？ 熟练的对水样、DS、原辅料和环境监控样品进行内毒素、微生物限度、微生物负载检测，对DP进行无菌检测。必要时进行促生长实验和微生物鉴别。确保及时完成检测需求。

Skilled perform endotoxin testing, microbiological limit and bioburden testing on water samples, DS samples, raw materials, and environmental monitoring samples; sterility testing for DP product; perform growth promotion and microbial identification if necessary. Ensure to complete incoming analytical requests timely.

？ 作为无菌控制领域的主题专家，负责工厂关键系统（包括灭菌、洁净室环境、水系统、洁净蒸汽系统和压缩空气系统）的微生物风险控制。

Responsible for microbial risk control for critical system (include sterilization, clean room environment, water system and compressed air system).

？ 更新完善洁净区环境、水系统、洁净蒸汽系统和压缩空气系统取样计划；

Update and improve the sampling plan for clean rooms environment, water system and compressed air system;

？ 回顾系统检测结果数据并进行分析，对异常趋势及数据发出警示并采取行动，跟进行动措施；

Review and analysis historical data of the test results, give out the warning and take action if abnormal trend was found, and follow up the actions;

？ 为工厂发生的微生物异常的调查提供技术支持；

Provide technical support for the investigation of microbial abnormalities in factories;

？ 与工厂其它部门合作，针对工厂的生产流程、设备设施情况，识别微生物风险并制定控制措施；

Identify microbial risk and set up control action in collaboration with other departments for production processes, equipment and facilities;

？ 工厂其它部门合作，回顾、更新并完善各部门清洁消毒计划，跟进清洁消毒方面的问题，为工厂的清洁消毒提供技术支持。

Work with other departments to review, update and improve the cleaning and disinfection plan, follow up the problems in the side of cleaning and disinfection, and provide technical support for the cleaning and disinfection of the factory.

？ 针对工厂项目，提供微生物方面的技术和风险评估。

To provide technical and risk assessment of microbial Control for factory projects.

？ 为工厂GMP年度培训中的微生物知识和无菌控制相关的培训支持。

To provide training support on Microbial knowledge and Aseptic control related topic of site annual GMP training program.

？ 执行公司安排的其他相关工作。

Execute any other related work assigned by company.

任职资格:

教育程度/经验 Education/Experiences

本科及以上学历，微生物相关专业

BS or above in Microbiology or equivalent

- 5年制药行业QC相关经验

5 years pharmaceutical quality control or relevant experience

- 3年无菌产品检测经验优先

3 years sterility product testing experience preferred

特别知识/技能 Specific Knowledge & Skills

熟悉GMP法规要求

Familiar with regulatory requirement on GMP

良好的沟通和制定计划能力

Good at planning and communicating

善于组织和合作

Capable of organizing, coordinating to deliver results as required

良好的英语（CET-6）和电脑操作能力

Good at English (CET-6) and computer operating