Job Information职位信息

Job title职位名称: Sterile Line Leader

• Grade级别: L1
• Location工作地点：北京
• % Remote working and % of travel expected 远程办公和出差的概率：10%
• Job type工作类型: Permanent长期, Full time全职,
• Site/Unit 区域/事业部：赛诺菲（北京）制药有限公司
• Solid Line Manager(Job Title and Name) ：直线汇报上级（职位名称+姓名）：灯检PCU副经理 李春萌
• Dotted Line Manager(Job Titel and Name)：无
• Job description valid from:修订时间：2025年03月

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：

Main job responsibilities主要工作职责。

Perform job responsibilities as a Process-Centric Unit Shift Lead

PCU倒班负责人履行工作职责：

• Leads the safe operation of the Level 1 shift operating unit on shift and supports Operators deliver on their responsibilities, through regular presence on the shopfloor 1 级倒班操作单元的安全运行，并通过定期在在车间支持操作员履行职责。
• Contributes to Level 1 +QDCI meetings and leads when needed (e.g. Asset Care routines...) 1 级 +QDCI 会议，并在需要时领导（例如资产维护例程......）
• Makes sure that data is collected, categorized and used correctly to make decisions . Builds capabilities of the Level 0 operating unit (shift team). 0 级操作层（轮班团队）的生产能力。
• Responsible for the shift work of sterile production (morning, middle and night).
• Responsible for reporting daily work and maintaining production and SAP data. SAP数据。
• Guide and supervise the whole process (including equipment preparation, production, room cleaning, etc.) of production on site to make sure all production activities comply with SOP requirements. 指导并监督生产现场全过程（包含设备准备、生产、房间清洁等），确保所有生产活动符合SOP要求。
• Sustainably  improve OEE and yield of inspection machine and ensure the stable supply to the market. OEE和收率，保证市场稳定供应。
• Responsible for communicating production-related information with relevant departments (such as communicating materials with warehouses, etc.)
• Verification activities are carried out in accordance with the requirements of report documents such as process, equipment, and cleaning Implement and monitor the actions of Change Control, CAPA for deviations or complaints related to production.
• To execute and follow the required initial and continous trainings of production operators.
• Develop necessary SOPs and ensure the implementation and improvement. To review the batch production records and related operational data as required.
• Implement SMS standards and continuously improve in 5S/HSE aspects and waste minimization. HSE、精益生产等方面持续改进。
• Report product complaints and adverse drug reactions according SOP requirements.SOP要求报告产品投诉和药物不良反应。
• Other tasks temporarily assigned by department  manager and supervisors. 按时完成上级临时交办的或部门间合作的其他工作任务。

Sterile production Department HSE Responsibilities 无菌生产部HSE职责

Responsible for following the company’s HSE policy and integrated all requires into daily job.

• HSE的有关规定，把公司HSE制度的措施贯彻到每个具体环节。

Incorporate HSE work into the work plan

• HSE工作纳入工作计划中。

Organize the implementation of HSE management target plan of this department, implement HSE rules and regulations, HSE operation procedures and HSE technical action plan.

• 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.

• 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.

• 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.

• 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.

• +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.

Sanofi (Beijing) Pharmaceutical Co., Ltd. Energy Policy: "Quality as the top priority, through technical, behavioral, human consciousness, continuously reduce the rate of energy consumption in product value, benefit the users, and promote company development". Good awareness of energy conservation is required, participate in energy saving actions, and assist in the continuous development of the energy management system.

赛诺菲（北京）制药有限公司能源方针：“以药品质量为第一要务，通过技术手段，行为规范，人为意识，不断降低产品价值中的能耗比重，造福广大用户，促进企业发展”要求每位员工具有良好的节能意识，积极的节能行动，协助能源管理体系的持续开展

Actively propose energy-saving projects 极提出节能方案 Coordinate and support the development of energy-saving projects and give positive feedback 并支持节能项目的制定，积极反馈意见 Coordinate and participate in the implementation of energy-saving projects 并参与节能项目的执行

About you 任职资格:

• Experience:

工作经验: 8年以上制药岗位工作经验。

• Soft skill:

通用技能: GMP、5S、Lean及其他相关培训。

• Technical skill:

专业技能: 能够熟练使用办公软件；良好的GMP与无菌灌装知识；良好的沟通和组织协调能力；善于发现并推进持续改进。

• Education:

教育背景: 大专及以上学历，制药或相关专业。

• Languages:

语言要求: 基本的英语阅读能力。

• Play to Win Behaviors: Stretch; Take Action; Act for Patients & Customers; Think One Sanofi

全力致胜行为: 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