M&S-Head of Inspection PCU _Fill & Finish-Beijing

Job title职位名称: Head of Inspection PCU _Fill & Finish

• Location工作地点： Beijing北京

About the job工作职责

Main responsibilities职责描述：

1.         Assist dept. manager to coordination of Project, plan, Quality and engineering to organise production with right volume, right quality, right cost and on right time. Supervise production, human resources, facilities to ensure all activities comply with China GMP and Sanofi regulations. Keep continuously improvement in terms of safety, quality, cost, delivery, motivation and environment.

协助部门经理有效协调项目、计划、质量、工程等资源，按时保质保量地组织生产。有效监控生产活动、人员、设备设施确保所有生产活动和过程符合中国GMP和赛诺菲内部规范的要求，推动安全、质量、成本、生产任务的达成、激励和环境方面的改善。

2.         Continuously improve the compliance level of sterile production, attend and promote SMS execution, Lean manufacturing.

3.         不断提高无菌生产的法规符合性和质量保证水平，参与并推进赛诺菲制造体系的深度实施和部门的精益生产。

4.         Organize, coordinate, track and implement of deviations, changes, validation, complaints and global standards gap analysis etc.

5.         组织、协调、跟进和实施偏差、变更、验证、投诉以及总部标准差距分析。

6.         To ensure the continuous process compliance improvement through the management of quality systems.

7.         通过质量体系的管理确保生产工艺合规的持续改进。

8.         To ensure the implement of quality policy/objectives of Sanofi and to ensure the quality compliance of sterile production operation.

9.         贯彻执行公司的质量方针和质量目标，确保无菌生产运营的质量合规性。

10.       To ensure effectiveness of sterile production quality improvement programs/projects.

确保无菌生产运营的质量改进计划或项目的有效性

KEY ACCOUNTABILITI关键职责

1.         Perform the job duties of the Inspection Process-Centric Unit Lead.

履行灯检PCU负责人的工作职责

-Takes responsibility for the 24h performance of the Level 1 Operating Unit and defines priorities for the day/week/month.

负责1级操作层面的24h绩效，并制定日常日/周/月的工作优先级。

-Ensure that standards of SMS2.0 are followed (incl. Role cards, standard workplan, planning adherence, standard times, Asset Care activities.

确保遵循 SMS2.0 的标准（包括角色卡、标准工作计划、计划遵守情况、标准时间、资产维护活动。

-Make sure that improvements opportunities on the assets/processes/scheduling are correctly escalated and contribute to CI.

确保资产/工艺/计划上的改进机会并正确上报，并为 持续改进做出贡献。

-Attend to and lead Level 1 and Level 2 meetings (+QDCI Level 1 and Level 2, CI Level 1 and Level 2, Asset care, Deviation management, E2E flow...).

参加并领导 1 级和 2 级会议（+QDCI 1 级和 2 级、CI 1 级和 2 级、资产维护、偏差管理、E2E 流程......

-Reviews performance and contributes to upskilling PCU members.

审查绩效并有助于提高 PCU 成员的技能。

2.         Responsible for the shift work of PCU production (morning, middle and night).

负责PCU生产现场倒班（早、中、夜）工作。

3.         Actively participate in product transfer project, including training and related validation execution etc.

积极参与无菌生产项目的产品转移，包括培训和相关验证工作执行。

4.         Optimize the production process, improve the equipment and system, consistently supply high quality production for commercial operation preparation

优化生产工艺，改进设备和系统，保证始终如一地生产出合格产品，为正式商业运作的准备。

5.         Sustainably improve yield of compounding, filling and inspection equipment and ensure the stable supply to the market.

持续提高配制工艺收率，保证市场稳定供应。

6.         Management of the production environment, process, hygiene, facilities to make sure all production activities comply with drug master file, SOPs and GMP requirements.

生产环境、工艺、卫生、设施等的管理，确保生产活动符合工艺规程、SOP和GMP要求。

7.         To review the batch production records and submit to Quality in time.

审核批生产记录，及时送交质量部门。

8.         To implement the equipment qualification, process validation according to the master plan.

按照计划执行完成区域内的设备的确认和工艺验证。

9.         To execute and follow the required initial and continuous trainings of production operators.

对生产相关人员进行必要的上岗前培训和继续培训，并根据实际需要调整培训内容。

10.       Organize daily production meeting, coordinate all shifts and keep closely communication with planning, QA, maintenance and warehouse etc., to implement production plan strictly and ensure right Plant Service Level and Bias.

组织日常生产协调会，协调各生产班组的活动及与质量、计划、维修、仓库间的沟通，严格执行生产计划，确保生产计划完成率及生产计划符合性。

11.       Follow up the actions of Change Control, CAPA for deviations or complaints related to production.

确保生产中所有变更、偏差及生产相关的投诉问题纠正措施和预防措施的及时落实及有效性。

12.       Develop necessary SOPs and ensure the implementation and improvement.

组织制定相关的岗位操作规程并确保执行及持继改进。

13.       Implement SMS standards and continuously improve in 5S/HSE aspects and waste minimization.

贯彻落实赛诺菲制造系统标准，在HSE、精益生产等方面持续改进。

14.       Report product complaints and adverse drug reactions according SOP requirements.

根据SOP要求报告产品投诉和药物不良反应。

15.       Participate in process optimization, equipment improvement and technique innovation to sustainably improve OEE and yield, participate in SMS standards deep execution and continuously improve in 5S/HSE aspects and waste minimization.

参与工艺优化、设备改进和技术创新，持续提高产品收率和设备利用率，参与赛诺菲制造系统标准的贯彻落实，在HSE、精益生产等方面持续改进。

16.       Other tasks temporarily assigned by department manager.

按时完成上级临时交办的或部门间合作的其他工作任务。

About you 任职资格:

At least a bachelor or above degree in pharmacy or biology disciplines with minimum 10 years’ experience in quality or sterile area. Must be a committed "Quality or Sterile" professional with knowledge of quality systems within the pharmaceutical or related industry.

至少药学或生物学相关专业大学本科及以上学历，至少10年质量或无菌领域工作经验。必须具备制药或相关行业的质量体系的“质量或无菌”专业知识经验。

•Thorough understanding of manufacturing processes and aseptic processes

全面理解生产流程和无菌工艺

•Strong working knowledge of quality systems, regulatory requirements across multiple health authorities.

质量系统和各相关法规要求等方面具有工作经验。

•Fluent English both in written and verbal

熟练的英语口语与书写能力

•Good communication skills

良好的 沟通能力

•Able to burden pressure

能够耐受压力

•Brave to make decision

果敢决策

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.

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