Job title职位名称: PCU Lead

• Location工作地点: shenzhen 深圳

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 PCU Lead within our M&S China-Shenzhen Site will be responsible for shop floor quality assurance and compliance.

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。

Shop Floor Quality Assurance

• Issue shop floor oversight SOP/ oversight plan and participate the implementation of the oversight plan. Timely communicate oversight should include the implementation of quality system on the shop floor. Communicate with QS if necessary.
• Verify batch manufacturing instruction and review batch records.
• Review or approve documents related to GxP operations and shop floor management.
• Participate in deviation investigation of process and supporting activities to ensure the effectiveness of investigation and CAPA.

• Organizes participation in deviation investigation progress meetings, assists in resolving issues during deviation investigation, and escalates meeting results as appropriate.
• Supporting the preparation of annually product report.
• Participate in change control assessment and risk assessment of manufacturing process and its supporting activities.

• Responsible for trending analysis of utilities, environment and cold chain; assist the CAPA definition process with system owners.
• Participate in self-inspection and supplier audit; assist the regulatory inspection.

Compliance & Others

• Assist in establishing and achieving Quality department goals. Ensure that all relevant information relating to activities within your scope are tracked, captured and forwarded in due time to the head of department.
• Based on the Site strategy, develop specific solutions to achieve the department and company objectives.
• Ensure HSE8 is followed for all activities within working area.
• Understand and participate to the implementation of budgeting and cost control.
• Other works assigned by line Manager.

生产现场质量监督和管理

• 现场督导标准操作规程的起草'制定现场督导计划'参与现场督导的实施。对于现场督导中产生的问题与区域主管或经理进行及时沟通'如需上报。现场督导工作也包含对现有质量体系的现场执行情况。
• 负责确认批生产指令'审核批生产记录的填写情况。
• 负责审核或批准与GxP现场操作,管理相关的文件。
• 参与生产及其支持性活动中的偏差,异常情况的处理'确保调查活动及纠正预防措施的有效性。

• 组织参与偏差调查进度会'协助解决偏差调查过程中的问题'并适时上报会议结果。
• 支持产品年度质量回顾的准备。
• 参与生产及其支持性活动相关的变更评估和风险评估。

• 负责公用系统,环境,冷链等质量趋势的回顾分析和总结'协助相关系统负责人共同就趋势分析的结论定义有效的纠正和预防措施。
• 参与工厂自检和供应商审计'协助法规审计的准备及审计过程。

合规及其它

• 协助建立和达成质量目标'确保所有职责范围内的活动被有效跟踪'执行'并适时汇报相关的信息。
• 基于工厂的总体策略'设计相应的解决方案'以达成部门和公司总体目标。
• 确保工作场所内所有的活动遵从HSE8的要求。
• 参与预算和成本控制活动。
• 直线经理分配的其它工作。

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:

• At least 5 years of relevant experience in the pharmaceutical industry preferably in Biologics.
• 拥有在疫苗/化学制药上至少5年的工作经验'生物制药优先。

• Soft skill:

• A sense of leadership & change
• Risk management skills
• Good planning, organization, communication and coordination skill
• Performance and achievement oriented
• 良好的人员管理及领导技巧
• 良好的风险管理意识和技巧
• 良好的计划,组织,沟通和协调能力
• 以绩效和成绩为导向

• Technical skill:

• Excellent knowledge of quality pharmaceuticals plants.
• Good knowledge of cross functional business processes
• 在质量管理方面有丰富的知识
• 良好的其它部门管理流程的知识和经验

• Education:

• University qualification or above, pharmaceutical and /or biological related background.
• 持有药学,生物,化学或相关专业领域学士以上学位。

• Languages: English and Mandarin.

语言要求: 英语和普通话。

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!