Job Description

Job title职位名称 Lab Manager and PCU Manager -Physico Chemistry

• 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 Lab Manager and PCU Manager -Physico Chemistry 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：

监督质量控制实验室的日常运营，以确保遵守承诺的计划

根据内外部质量要求和法规定义的 GMP 和质量控制流程，维护其实验室

确保在其管理范围内使用经验证的方法，并作为接收单位执行任何验证/转移方案

管理和培训实验室工作人员，确保他们遵循最佳实践和安全指南

通过维护实验室资质矩阵，确保其实验室工作人员有资格执行测试

开展实验室现场的常规检查，以确定改进机会

确保其管理范围内准确及时地检测收到的样本

代表质量控制负责人，就分析批记录的质量标准和合规性分析测试结果的一致性得出结论，以支持产品批次的放行

通过应用维护、鉴定和校准计划来维护实验室设备，以确保实验室活动的准确性和可靠性

确保及时跟进和推进分配给他/她的范围内的调查、变更控制和 CAPA

及时调查并解决其范围内的任何质量控制事件、问题或差异。根据发现项和 CAPA 实施补救措施

在监管检查和审计期间，通过回应与其职责相关的请求提供支持

确保他/她的实验室/设施、实验室仪器保持质量和安全状态，以确保它们能够得到适当使用

Overseeing daily operations of the quality control laboratory to ensure adherence to the committed scheduled plans

Maintaining his/her laboratory in compliance with the GMPs and quality control processes defined according to internal and external quality requirements and regulations

Ensuring the use of validated methods in his/her perimeter and executing any validation/transfer protocol as receiving unit

Managing and training laboratory staff, ensuring they follow best practices and safety guidelines

Ensuring his/her laboratory staff is qualified to perform the testing execution by maintaining the lab qualification matrix

Conducting routine shopfloor of laboratory to identify improvement opportunities

Ensuring accurate and timely testing of received samples according to his/her perimeter

Concluding on the conformance of analytical test results with regards to specifications and compliance of analytical batch record to support the release of product batches, on behalf of the head of quality control

Maintaining laboratory equipment by applying maintenance, qualification, and calibration plans to ensure accuracy and reliability of lab activities

Ensuring the follow-up and progress of the investigations, change control, and CAPAs assigned to his/her perimeter, in a timely manner

Investigating in a timely manner and resolving any quality control events, issues, or discrepancies from his/her perimeter. Implementing remediation actions from findings and CAPAs

Providing support during regulatory inspections and audits by answering requests related to his/her perimeter

Ensuring that his/her lab/facilities, lab instruments are kept in a quality and safety status to ensure that they can be used appropriately

About you 任职资格

Bachelor degree or above in chemistry, pharmacy or relative majors with minimum of 3 years related work experience.

化学、制药或相关专业学士学位,至少3年相关工作经验

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!

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But 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. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

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