Main responsibilities职责描述： Please indicate here the main job responsibilities请列举该职位的主要工作职责。 1. To ensure the operations in environmental monitoring fulfill the GMP requirement. Prepare the relevant specifications and analytical test methods to ensure the routine monitoring of the manufacturing area is correctly performed. 2. 确保环境监测相关的日常工作遵循GMP的要求得以执行并满足业务需求。准备和开发相关质量标准和分析检验方法确保工厂的日常监控的执行。 3. Be responsible to projects and continuously improvement, validation and investigation in EM and sterile assurance 4. 负责环境监测及无菌保证相关的项目及持续改善，验证及调查工作。 5. Support in implementation of contamination control strategy (CCS) and sterile product manufacturing to prevent contamination, and contribute to the trouble shooting for sterility/microbe contamination issue in EM, equipment, utility, material, product and production related validation etc. 6. 支持污染控制策略的实施及无菌产品生产防止污染，并解决环境监控，公用工程，工艺设备，物料，产品检测，以及生产车间的相关验证中的微生物污染或无菌检验结果的异常。 7. Developing or assisting the develop microbial/EM assessment SOP to support routine operation, e.g. EM and utility monitoring and testing. 8. 准备或协助准备微生物/环境监测相关标准操作规程来支持日常工作，比如环境监测及公用设施监测及方法等文件。 9. Ensure that monitoring is carried out in compliance with specifications, Pharmacopeia requirements and the cGMP and analyse the trend of the analytical results. Ensure the exceeding limit investigation is conducted properly. 10. 确保执行的监测符合质量标准、药典的要求和GMP的要求，并分析检验结果的趋势。确保正确执行对超限结果的调查。 11. Keep close relationship and communication with other departments to ensure proper execution of the production plan. 12. 与相关部门保持密切联系和沟通以确保生产计划的执行。 13. Implement GAP analysis for global requirement and local authority standard and take CAPA actions related to EM，CCS and gowning. 14. 执行EM，CCS，更衣相关总部要求及本地法规标准的差距分析，并且实施纠正预防措施。 15. Support in clean zone re-construction, process optimization, people’s awareness enhancement, utility control from contamination control and microorganism monitoring perspective. 16. 从污染控制和微生物监控方面提供支持，包括针对洁净区改造，无菌工艺优化，人员意识提升，公用工程监控等。 17. Participate in the investigation for sterility/microbe contamination issue in EM, equipment, utility, material, product, APS etc. 18. 参与环境监控，公用工程，工艺设备，物料，产品检测，无菌模拟灌装中的微生物污染或无菌检验结果异常的调查。 19. Support in implementation of the CCS (contamination control strategy). 协助污染防控策略的实施。 20. Support in technical training deployment in site level regarding to the contamination control. 协助在工厂内开展污染控制有关的技术培训。 21. As SA role, participate in the expert assessment regarding contamination control related change control. 作为无菌保证角色，参与污染控制相关的变更的专家评估。 22. Participate in related inspection, to answer auditor’s questions as Sterility Assurance SME, and corporate with such as production and engineering department to answer SA related questions. 在各种审计过程中作为无菌保障专家参与审计问题的回答，以及协助如生产和工程等部门回答涉及SA的相关审计问题。

• Experience: 工作经验: A minimum of 3 years’ QA/SA experience for sterile products, experience in microbiology analytical methodologies and management is preferred. 至少3年以上无菌产品QA/SA工作经验，有微生物分析和管理工作经验佳。 • Soft skill: 通用技能: Must be problem solving oriented. Good communication and cooperative ability 须具备善于解决问题的能力和主动性。具备良好的沟通和协调能力 • Technical skill: 专业技能: A good knowledge of Chinese and international GMP are required. 要求了解中国和国际GMP要求。 • Education: 教育背景: A B.S degree or above in Chemistry, Pharmacy and Biology, or other related disciplines, preferred major in Microbiology 化学、药学和生物或相关专业学士学位及以上，优选微生物专业。 • Languages: 语言要求: Good English listening, writing and spoken 英语听、说、写良好。 • Play to Win Behaviors: 全力致胜行为: Stretch; Take Action; Act for Patients & Customers; Think One Sanofi 超越自我, 主动出击, 以患者和客户为本, 团结一致