Job title职位名称: Sterile Production Manger

• Location工作地点： Beijing, China M&S; 中国北京

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 Sterile Production Manger within our M&S China-BEI Site, we are committed 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：

Please indicate here the main job responsibilities请列举该职位的主要工作职责。

• As the PCU Lead of the 2nd filling line to organize cross-departmental collaboration to complete the qualification and validation (including moist heat sterilization (autoclave, SIP), dehydrogenization(tunnel), gas sanitization (VHP), equipment cleaning (CIP, washing machines, manual cleaning), Isolator /LAF and clean room in general, clean validation, process validation, APS validation) etc...

作为第2条生产线的PCU Lead 组织协调跨部门工作，完成生产线设备的确认与验证（包括：湿热灭菌柜、SIP，干热灭菌隧道，气体消毒VHP，设备清洁：CIP、清洗机、人工清洁，隔离器/LAF和一般洁净室，清洁验证，工艺验证、无菌工艺模拟验证等

• Establish the second production line operation 、maintenance 、calibration and HSE SOP etc.

建立第2条生产线操作、维修维护、校准和HSE SOP等

• Establish the second production line MPI and batch record.

建立第2条生产线批生产工艺规程与批生产记录等

• Establish the second production line equipment and facilities regularly validation protocol and strategy.

建立第2条生产线设备设施定期验证方案与策略

• Communicate and cooperate with Sanofi global experts and play a key contributing role to the related Communities of Practice.

与赛诺菲全球专家进行沟通和合作，为团队发挥关键贡献作用。

• Continuous improvement of the processes and practices in the aseptic departments’ compliance according to the global quality directives/standard/cGMP.

根据总部质量放针/标准/CGMP持续改进无菌生产的工艺和操作合规水平。

• Follow up the actions of Change Control, CAPA for deviations related to 2nd production.

确保第2条生产线中所有变更、偏差等问题纠正措施和预防措施的及时落实及有效性。

• Transform from English Sanofi training or develop training material and deliver training on manufacturing process and aseptic technique. Training 2nd line colleagues to ensure sustainable compounding and aseptic operational knowledge across the staff including operations, engineering, and quality organization.

翻译或开发培训材料，并提供有关生产工艺和无菌技术的培训，培训第2条生产线员工，以确保员工（包含生产、工程和质量）具备可持续的配制和无菌操作知识。

• Learn and improve SMS knowledge, implement SMS2.0 standards and coach dept. 2nd line colleagues.

学习并提高赛诺菲制造系统知识，贯彻落实SMS2.0标准，并培训第2条生产线员工。

• Maintain a good relationship with different departments and develop a team approach to promote team results.

与其他部门保持良好的合作关系，促进本部门的团队建设。

• Ensuring that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management.

确保及时有效的沟通及汇报流程，以将质量问题提交给适当的管理层。

• Respond flexibly to the tasks of the two lines at different stages, complement each other and support each other.

灵活应对两条线不同阶段的任务，相辅相成互相支持。

• HSE ACCOUNTABILITIES / HSE职责

• Establish 2nd line targets and implement based on site HSE principle and targets.
  • HSE方针和目标，参与制定并执行2线HSE管理目标并实施。
• To ensure HSE requirements and procedures implementation, operation as per SOPs with properly PPE.
• To ensure personnel to complete HSE before and during operation.
  • HSE教育和持续培训。
• Attend to onsite inspection routinely, HSE monthly meeting and organize HSE meeting.
  • HSE月度会议，并组织HSE会议。
• Organize HSE defects inspection, report HSE issue, assist to investigate and implement.

correction actions.

• 按照规定组织HSE隐患排查治理工作，及时报告安全、环保和职业健康事故，协助事故调查、分析，落实事故防范措施。
• Actively participate in and support energy-saving projects, raise energy-saving proposal based on production practice, attend to audit of energy management system.

• Other related business and task responsibilities assigned.

分配的其他相关工作任务。

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:

• 8 plus years operational experience in aseptic process including team leadership. Familiarity with Bosch equipment isolator is preferred.8年以上无菌工艺操作经验，包括团队领导。 熟悉博世设备隔离器者优先。
• Experience in aseptic equipment Qualification, PPQ, APS and PV, as well as process operations.具备无菌设备确认、PPQ、APS 和 PV 以及工艺操作方面的经验。
• Experience in a facility that was inspected and front room experience in inspections from EMA, TGA or FDA preferred.有接受过EMA,TGA 或FDA审计检查的经验。
• Deep understanding with Sanofi global aseptic requirements and guidance.深入了解赛诺菲总部对无菌的要求和指导。

• Soft skill:

通用技能:

• Influencing and leadership Skills 影响力和领导力

Establishment of good relationship with internal and external stakeholders与内外部利益相关者建立良好关系的能力

• Good communication skills 良好的沟通技巧
• Excellent teamwork / team player and management skills.卓越的团队合作与管理技能
• Ability and willingness to coach other colleagues. 有能力且愿意指导其他同事

• Technical skill:

专业技能:

SMS certification, Problem solving and diagnostic ability.

SMS认证，解决问题和逻辑诊断能力

• Education:

教育背景:

Bachelor’s degree education or above, with major on pharmaceutical or related.

本科及以上学历，制药或相关专业

• Languages:

语言要求:

Fluent English

英语流利

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!