Job title职位名称: Sterility assurance lead

• Location工作地点： Beijing北京

About the job工作职责

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Your job, as Sterility assurance lead within our M&S China-BEI Site, will be to making best class medicines with excellent strategies and tools and delivering them to our patients.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main responsibilities职责描述：

• Developing and implementing comprehensive sterility assurance and microbiological

programs in alignment with the organizational strategy, vision, and objectives

根据组织战略、愿景和目标，制定和实施全面的无菌保证和微生物计划

• Developing and implementing effective strategies and procedures for sterility

assurance and microbiology across the organization (environment, water, steam, gas,

bio-cleaning, gowning, aseptic processes and practices and industrial supplies, etc.) and Qualification/Validation for processes (microbio strategy)

制定和实施有效的战略和程序,确保整个组织无菌和微生物学（环境、水、蒸汽、气体、生物清洁、更衣、无菌流程和实践以及工业用品等），以及流程认证/验证（微生物战略）

• Ensuring the compliance of products and processes with applicable sterility assurance and microbiology regulatory requirements and company quality standards

确保产品和流程符合适用的无菌保证和微生物监管要求以及公司质量标准

• Maintaining a system to ensure sterility assurance and microbiological risks are

properly identified, tracked and mitigated

维护系统，确保正确识别、跟踪和缓解无菌保证和微生物风险

• Overseeing of production activities as (MFT, best aseptic practices ....)

监督生产活动（MFT，最佳无菌实践......）

• Overseeing, with Q&V team, the validation, qualification, and monitoring of methods,

equipment, and the environment ensuring sterility assurance control

与 Q&V 团队一起监督方法、设备和环境的验证、确认和监控，确保无菌保证控制

• Following metrics and monitoring data for the sterility assurance and microbiological

activities to identify trends and issues and to implement action plan

遵循无菌保证和微生物活动的指标和监测数据，以确定趋势和问题，并实施行动计划

• Establishing and monitoring key performance indicators (KPIs) and metrics for the

sterility assurance and microbiological activities and reporting on its performance and

effectiveness

建立和监控无菌保证和微生物活动的关键绩效指标（KPI）和指标，并报告其性能和有效性 • Promoting a culture of quality throughout the organization

在整个组织内推广质量文化

• Identifying and driving continuous improvement initiatives and projects to enhance the sterility assurance and microbiological activities

确定并推动持续改进计划和项目，以增强无菌保证和微生物活动

• Evaluating and recommending new technologies, tools, and methods to enhance

sterility assurance and microbiology

评估和推荐新技术、工具和方法，以增强无菌保证和微生物学

• Leading management reviews to assess the effectiveness of the sterility assurance

program and microbiological program

领导管理层审查，以评估无菌保证计划和微生物计划的有效性

• Leading and managing the sterility assurance and microbiology team, including hiring, training, coaching, professional development, and performance evaluation

领导和管理无菌保证和微生物学团队，包括招聘、培训、辅导、职业发展和绩效评估

• Interacting with external bodies and Global Quality to bring knowledge and awareness of best industry practices (Congress, CoP and CoE)

与外部机构和全球质量部门互动，以提升对最佳行业实践（Congress、CoP 和 CoE）的知识和认识

• Preparing and participating in regulatory inspections and audits, providing expertise on sterility assurance and microbiology

准备并参与监管检查和审计，提供无菌保证和微生物学方面的专业知识

• Providing support for the successful collaboration between Digital, Quality, and technical functions to achieve desired functionality, compliance, and productivity for new solutions in Sterility Assurance and Environmental Monitoring areas

为数字、质量和技术职能部门之间的成功合作提供支持，以实现无菌保证和环境监控领域新解决方案所需的功能、合规性和生产力

•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

Why choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

Pursue Progress. Discover Extraordinary.

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. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.

At Sanofi, we provide equal opportunities to all regardless of race, color, 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!

Pursue progress, discover extraordinary

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, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!