M&S-Head of Fill & Finish-Beijing

Job title职位名称: Head of Production and AD of Fill & Finish生产管理负责人兼无菌生产副总监

• 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 Head of Production and AD of Fill & Finish 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：

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

Generic 通用

The Head of Production generally has the following responsibilities:

Fully responsible for the GMP work of all production departments in the Beijing Site, including Sterile production, A&P production, solid production and packing production.

1.    To ensure that products are produced and stored according to the appropriate documentation in order to obtain the required quality.

2.    To approve the instructions relating to production operations and to ensure their strict implementation.

3.    To ensure that the production records are evaluated and signed by an authorised person.

4.    To ensure the qualification and maintenance of his department, premises and equipment.

5.    To ensure that the appropriate validations are done.

6.    To ensure that the required initial and continuing training of his department personnel is carried out and adapted according to need.

生产管理负责人通常职责如下：

全面负责北京工厂所有生产部门GMP工作，包含无菌生产，组包装生产，固体生产与外包生产。

1.    确保药品按照批准的工艺规程生产、储存，以保证药品质量；

2.    确保严格执行与生产操作相关的各种操作规程；

3.    确保批生产记录和批包装记录经过指定人员审核并送交质量管理部门；

4.    确保厂房和设备的维护保养，以保持其良好的运转状态；

5.    确保完成各种必要的验证工作；

6.    确保生产相关人员经过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。

Associate Director of Fill & Finish generally has the following responsibilities:

1.    Overall management of Line1 and Line2 activities and staff, coordination of plan, quality, engineering and supply etc.

2.    To guarrantee the target of volume, quality, OEE, yield, audit realization.

3.    Participate and implement the technique transfer project related to sterile filling.

兼任无菌生产副总监通常职责如下：

1.    全面负责无菌灌装1线和2线的生产组织、人员管理、质量管理；

2.    并协调计划、质量、工程、供应等资源，确保产量、质量、OEE、收率、审计等目标和任务的达成；

3.    参与并实施无菌灌装相关技术转移项目。

KEY ACCOUNTABILITI关键职责

1.    As the Production Head of Sanofi Beijing site in charge of GMP production management.

作为北京工厂企业生产负责人，行使GMP生产职责。

2.    AS the Autonomous Production Unit Head in charge of production management.

作为无菌生产APU负责人履行工作职责。

3.    Manage and organize production activities and staff, monitor environment, process, hygiene, facilities to make sure all production activities comply with drug master file, SOPs and GMP requirements.

组织和人员管理、并监控环境、工艺、卫生、设施等的运行，确保生产活动符合工艺规程、SOP和GMP要求。

4.    Organize and coordinate quality, planning, maintenance and warehouse ect, to implement production plan strictly and ensure production plan and volume realization.

组织并协调质量、计划、维修、仓库，确保生产计划和产量目标的达成。

5.    Optimize the production process, improve the equipment and system, improve OEE and yield of filling and inspection process, consistently supply high quality products.

优化生产工艺，改进设备和系统，持续提高灌装和灯检设备的OEE和收率，保证始终如一地生产出合格产品。

6.    To review procedures, records, drug master file, BMR &BPR and other GMP documents, to ensure scientific, rational and correct.

审核操作规程、记录，产品的工艺规程、批生产记录和批包装记录以及其他GMP相关文件，确保其科学性、合理性和正确性。

7.    To ensure the key equipment’s qualification, process validation according to master plan.

确保负责区域内的关键设备，生产工艺按照验证计划完成相应的确认和验证

8.    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。

9.    To ensure the required initial and continuous trainings to production personnel are carried out and adapted according to needs.

确保生产相关人员经过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.  To review the batch production records and batch packaging records and submit to Quality in time.

审核批生产记录和批包装记录，及时送交质量部门。

11.  Actively participate in product transfer project, including key process control, training and related validation execution etc.

积极参与生产项目的产品转移，包括工艺关键控制、培训和相关验证工作执行。

12.  Learn and improve SMS knowledge, implement SMS standards and coach dept. colleagues.

学习并提高赛诺菲制造系统知识，贯彻落实SMS标准，并培训他人。

13.  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。

14.  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。

15.  Setting department objectives and periodically review performance.

设定部门计划与目标，定期对目标完成情况进行回顾；

16.  Prepare annual departmental budget and manage spending accordingly.

准备部门年度预算并负责相应的开支管理；

17.  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。

18.  The heads of Production generally have some shared, or jointly exercised, responsibilities relating to quality including in particular the design, effective implementation, monitoring and maintenance of the Pharmaceutical Quality System. These may include, subject to any national regulations:

生产管理负责人通常有一些共同或共同行使的与质量相关的责任，特别是药品质量体系的设计、有效实施、监控和维护。 包括如下方面：

• The authorisation of written procedures and other documents, including amendments.
• The monitoring and control of the manufacturing environment.
• Plant hygiene; 工厂卫生；
• Process validation; 工艺验证
• Training; 培训
• The approval and monitoring of suppliers of materials; 物料供应商的审批与监控；
• The approval and monitoring of contract manufacturers and providers of other GMP related outsourced activities.

其他 GMP 相关外包活动的合同制造商和供应商的批准和监督；

• The designation and monitoring of storage conditions for materials and products.
• The retention of records; 记录存档；
• The monitoring of compliance with the requirements of Good Manufacturing Practice.
• GMP执行情况；
• The inspection, investigation, and taking of samples, in order to monitor factors which may affect product quality; 巡检、调查和取样，来监测可能影响产品质量的因素；
• Participation in management reviews of process performance, product quality and of the Pharmaceutical Quality System and advocating continual improvement.
• 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。

Principle Accountabilities

责任说明

• Responsible for drug production management
• Ensure that the drug is produced and stored in accordance with the approved process regulations to ensure the quality of the drug.
• Ensure strict implementation of SOP related to production operations.
• Ensure that batch production records and batch packaging records are evaluated and signed by an authorised person; sent to the quality management department.
• Ensure that all necessary verification work is completed.
• Ensure the effective operation of the production management training system and conduct training and assessment for all personnel involved in drug production management. Ensure that production-related personnel undergo necessary pre-employment training and continuing training and adjust the training content according to actual needs.

HSE ACCOUNTABILITIES / HSE职责

1．  Establish dept. targets and implement based on site HSE principle and targets.

根据公司HSE方针和目标，参与制定并执行部门HSE管理目标并实施。

2．  To ensure HSE requirements and procedures implementation, operation as per SOPs with properly PPE.

确保部门员工按照操作规程生产，确保个人防护用品的正确使用。

3．  To ensure dept. personnel to complete HSE before and during operation.

确保部门员工完成岗前HSE教育和持续培训。

4．  Attend to onsite inspection routinely, HSE monthly meeting and organize dept. HSE meeting.

按照规定参加月度现场检查，HSE月度会议，并组织部门HSE会议。

5．  Organize dept. HSE defects inspection, report HSE issue, assist to investigate and implement.

correction actions. 

按照规定组织部门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。

ENERGY SAVING ACCOUNTABILITIES  能源管理职责

Actively participate in and support energy-saving projects, raise energy-saving proposal based on production practice, attend to audit of energy management system.

积极参与、支持公司节能减排项目，根据生产经验提出节能方案，参与能源管理体系的内部评审。

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。

Bachelor’s degree education or above, with major on pharmaceutical or related.  
10+ years production management related the working experience of pharmaceutical industry. 年以上制药生产管理岗位工作经验。 GMP,  5S 、Lean etc. related training. 、5S、Lean及其他相关培训 Good English communication skill (written and verbal)
Good communication and coordination skills.
Excellent teamwork / team player and management skills.
Be good at continuous improvement.

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.

PursueProgress. 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.