M&S-Sterile Process Compliance Specialist-Beijing

Job Information职位信息

Job title职位名称: Sterile Process Compliance Specialist 无菌工艺合规专员

• Location工作地点： Beijing北京
• Job type工作类型: Permanent长期
• Site/Unit 区域/事业部：赛诺菲（北京）制药有限公司 Sanofi (Beijing) Pharmaceuticals Co., Ltd

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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 CSV Engineer 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

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

2.    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。

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

4.    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。

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

6.    通过质量体系的管理确保生产工艺合规的持续改进。

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

8.    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。

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

10.  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.    Organize, coordinate, track and execute sterile production related investigation of deviations, complaints and correction actions, keep close communication with quality to improve the investigation compliance level.

组织、协调、跟进和执行无菌生产相关偏差、投诉的调查及整改措施的落实情况，与质量部保持良好的沟通，不断提高调查的符合性水平。

2.    Participate in and lead sterile production related changes, guarantee the change compliance through regulation understanding.

参与、领导无菌生产相关的变更，通过不断增进法规理解保证变更的符合性。

3.    Establish and assure a continuous GMP training to maintain an high level of  GMP awareness in all the staff. 

建立并持续开展GMP培训以维护全体员工高水准的GMP意识。

4.    Be familiar and enhance global standards understanding, lead sterile production related gap analysis and implementation.

熟悉并增进总部相关标准的理解，领导相关标准的差距分析并贯彻实施。

5.    Coordinate the validation execution of process, equipment, cleaning and execution according to the master plan.

协调并跟进部门相关的工艺、设备、清洁等验证工作，保证按照计划实施。

6.    Monitor production environment, process, hygiene, facilities and personal behavior and make proposal for improvement, to make sure the activities comply with SOP requirements，

监督生产环境、工艺、卫生、设施、人员行为方式等，提出改善措施，确保生产活动符合SOP要求。

7.    Lead and coordinate department resource to attend self-inspection, authorities inspection and global quality audit.

领导并协调部门资源，应对自检、药监部门的检查以及总部质量审计。

8.    Manage procedures to correct deviations and out of specification results and monitor the corrective and preventive actions (CAPA) to prevent the repetition of the not compliance instance.

有效管理偏差和OOS程序并监控整改和预防性整改措施的落实以预防不符合事件的重现。

9.    Ensures quality risks are properly managed (identification, assessment, control, communication). 

确保质量风险得到适当管理（识别、评估、控制和沟通） 。

10.  Assure the correct handling of product recall and customer complaints.

保证正确处理产品召回和客户投诉。

11.  Ensure effectiveness of gap analysis process .

保证差距分析流程的有效性。

12.  Involve site quality improvement projects/programs (compliance program, QMI, DIMM etc) to ensure the effectiveness of project/programs.

参与工厂质量改善项目或计划（如合规计划，质量成熟度评估，数据完整性成熟度评估等），以确保项目/计划的有效性。

13.  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。

14.  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。

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.

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。

➤Incorporate HSE work into the work plan

将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.

组织实施本部门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.

负责部门级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。

➤Responsible for design annual department PASS plan and ensure implementation as planned.

负责制定年度部门PASS计划，并按进度组织实施。

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

积极提出节能方案

➤ Coordinate and support the development of energy-saving projects and give positive feedback

协调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

协调并参与节能项目的执行

➤ Participate in internal audit of energy management system

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。

At least a bachelor or above degree in pharmacy or biology disciplines with minimum 2 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2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.

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.

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