Job title职位名称: Manager of Quality Assurance Operation
- Location工作地点: Beijing
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 Manager of Quality Assurance Operation 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?
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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。
- Act as the QA PCU Lead to respond to operational QA business for PCU.
- PCU质量保证团队的负责人负责相关的现场QA质量管理业务。
- Provide quality assurance oversight by performing routine walk-throughs and inspections on production, laboratory, warehouse, engineering deportment and other areas assigned where the business is responsible to ensure that all aspects of operations comply with cGMP legal and regulatory requirements as well as global guidelines
- cGMP,注册法规以及总部文件要求
- Ensure all batch records are reviewed, and when needs, ready for release as required, on behalf of site quality responsible.
- Ensure that all manufacturing/packaging activities comply with the validated processes and the relevant sops and cGMPs
- SOP和GMP要求。
- Establish procedures and ensure continuous improvement of the PCU quality oversight and GMP documentation.
- PCU质量运营监督的设计和GMP相关的支持文件。
- Manage the PCU deviation and related customer complaint, corrective and preventative actions (CAPA), out of specification (OOS) handling, and monitor the CAPAs to prevent the recurrence of the not compliance incidents; demonstrate a high level of independent judgment and discretion in the timely identification, investigation and resolution of deviations potentially impacting the quality of products and processes; providing support and advice during cross functional investigations and when required, devise sampling procedures and directions for recording and reporting quality data. As quality representative, approve deviation and lab investigation, to ensure the process handling meet the requirement of regulatory and Sanofi procedure.
- PCU偏差'纠正预防措施和OOS处理'并监控CAPA的落实以预防不符合事件的重现；需在工作中展现高度独立的,及时的判断决断能力；以及理清偏差对产品及工艺影响的能力； 如需要'在跨部门调查中提供支持和建议如提出取样方案'调查方向以及汇报相关质量数据。作为质量代表批准偏差及实验室调查'确保整个过程符合法规及总部要求。
- Support CAPA implementation and review CAPA effectiveness, approve the extension requests of CAPA in systems.
- CAPA执行和回顾CAPA效果'作为质量代表批准系统中CAPA的延期请求。
- Ensure the plan in place. ensures all critical process parameters and quality attributes are monitored or analyzed.
- Support and participate project or improvement of products and product launch and technical study. Ensure a proper prioritization approach for high-level product assessments, product validation, compliance activities
- Establish procedures and ensure continuous improvement of the operational quality oversight and GMP documentation.
- GMP相关的支持文件。
- Participate inspection, including the supplier inspection.
- Establish and assure a continuous GMP training to APU to maintain a high level of GMP awareness.
- GMP培训以维护APU员工高水准的GMP意识。
- Act as the final evaluator of change quality to ensure changes are properly evaluated
- Develop people via training and coaching to enable them qualified for QA PCU work. Training curriculum up to dat. Ensure associates trained according to the training curriculum.
- QA PCU工作要求。安装计划的要求实施培训'并保证培训及时更新。
- Perform people performance management. Make individual develop plan with personnel within team and build up technical ladder.
- Approval of relevant documents on behalf of the QA Manager when the QA Manager is absent.
- QA经理缺席时代表QA经理批准相关文件
- Any other specific responsibility appointed by the senior management.
- HSE responsibilities
- Responsible for implementing HSE requirements and implementing the measures of HSE to each specific link.
- 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。
- Regularly carry out HSE hidden dangers investigation and management work in this department, set up rectification plans and complete rectification of hidden dangers 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。
- Actively cooperate with HSE management to prevent various types of accidents.
- HSE 管理工作'防止各类事故的发生。
- Emerge responsibilities
- 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.
- "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
- Support the initiation, approval and implementation of energy-saving projects
- According the energy-saving plan, promote the implementation of energy-saving projects
- Participate in internal and external audit of energy management systems
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:
- Soft skill:
- Technical skill:
- Education:
- Languages:
英语口语和书写熟练
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!