Manufacturing and Supply
Wo Wunder
der Wissenschaft
für Patient*innen
Realität werden

Job Information 职位信息

Job title职位名称: Sterility Assurance Senior Specialist

•    Location工作地点： Beijing site北京工厂
•    % Remote working and % of travel expected 远程办公和出差的概率：<10%
•    Job type工作类型: Full time全职
•    Site/Unit 区域/事业部：Beijing SIte北京工厂

About the job工作职责

Our Team我们的团队：
Manufacturing & Supply consists of 3 manufacturing platforms based on global business units, as well as supporting functions of Quality, Market Supply and Strategy. We are committed to making best class medicines with excellent strategies and tools and delivering them to our patients.
制造与供应事业部包含以3个全球事业部为基础的制造平台，以及质量、供应商、精益战略等支持部门。致力于用优异的战略和工具制造优质的药品并传递到患者手中。

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。

• 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.
• 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。
• Be responsible to projects and continuously improvement, validation and investigation in EM and sterile assurance
• 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。
• 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.
• 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。
• Developing or assisting the develop microbial/EM assessment SOP to support routine operation, e.g. EM and utility monitoring and testing.
• 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。
• 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. 
• 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。
• Keep close relationship and communication with other departments to ensure proper execution of the production plan.
• 与相关部门保持密切联系和沟通以确保生产计划的执行。
• Implement GAP analysis for global requirement and local authority standard and take CAPA actions related to EM，CCS and gowning. 
• 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。
• Support in clean zone re-construction, process optimization, people’s awareness enhancement, utility control from contamination control and microorganism monitoring perspective.
• 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。
• Participate in the investigation for sterility/microbe contamination issue in EM, equipment, utility, material, product, APS etc.
• 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。
• Support in implementation of the CCS (contamination control strategy).
• 协助污染防控策略的实施。
• 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。
• 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。
• 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。

➤ Responsible for following the company’s HSE policy and integrated all requires into daily work. Incorporate HSE work into the work plan
负责贯彻公司HSE的有关规定，把公司HSE制度的措施贯彻到每个具体环节。将HSE工作纳入工作计划中。
➤ Participate the implementation of HSE management target plan of this department, implement HSE rules and regulations, HSE operation procedures and HSE technical action plan.
参与实施本部门HSE管理目标计划，落实HSE规章制度、HSE操作规程和HSE技术措施计划。
➤Regularly carry out to identify HSE potential hazards and develop action plan and finish on time.
定期开展本部门HSE隐患排查治理工作，制定整改计划并按时完成隐患整改。
➤Timely working out of employee opinions.
参与部门级HSE教育与考核工作；及时处理员工提出的意见。
➤Actively cooperate with HSE management to prevent accidents happens.
积极配合HSE管理工作，防止各类事故的发生。
➤ Regularly carry out +QDCI meetings at all levels considering HSE8 requirements. Feedback HSE issues in a timely and accurate manner, and actively implement remediation.
定期开展本部门各级+QDCI会议，结合HSE8要求，及时、正确填写和反馈各类HSE问题，并积极落实整改。
➤Participate in the investigation for accidents, analyze the root causes of accidents from the quality management perspective, and related CAPA.
参加事故调查分析工作，从质量管理角度分析事故原因，提出事故防范措施。

About you 任职资格:
List here ideally the must-haves criteria to be successful on the role. 
请列出胜任该职位所必须具备的条件。

•    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

Pursue progress, discover extraordinary进无止境，探索菲凡

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. 
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. 
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! 
进步，外部可见。更好的药物，更好的效果，更高的科学。但是进步离不开人去创造——来自不同背景、不同地区、担任不同岗位的人。所有人都团结在“创造奇迹的渴望”这一使命下。让我们成为这样的人。
在赛诺菲，不分种族、肤色、血统、宗教、性别、国籍、性取向、年龄、公民身份、婚姻状况、残疾或性别认同，我们为所有人提供平等的机会。
观看我们的 ALL IN 视频，并在 sanofi.com 网站上查看我们有关多元化、公平性、包容性的举措。

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Pursue Progress. Discovery Extraordinary.

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