Job Description

Job title职位名称 Project Quality Representative项目质量代表

• 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 Project Quality Representativewithin 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：

· 主导实验室调查，为实验室检测异常情况提供专业支持

· 主导分析方法转移至实验室，遵循MSAT的所有权管理

· 参与实验室相关的项目工作，支持项目在实验室的落地

· 确保分析方法按照法规指导原则进行验证

· 协调分析验证/转移方案的执行，确保按照承诺的计划时间表进行

· 定期对方法性能进行趋势分析，以确定是否需要重新验证、优化或更换方法

· 为分析方法提供技术专业知识和故障排除支持

· 编写和维护准确的分析方法程序以及分析验证主计划、方案和报告

· 对质量控制人员进行新分析方法和实验室仪器及自动化设备的培训

· 确保所有活动符合法规要求（如FDA、EMA）

· 对分析方法和实验室仪器/自动化设备进行风险评估

· 评估和推荐新的前沿技术和方法以提升质量控制活动，与MSAT和研发部门保持密切合作关系

· 在内部和外部审计及检查期间为QC团队提供支持

· 执行法规监察以了解行业趋势和法规变化的最新信息，确保持续合规（包括药典）

· Lead laboratory investigations and provide professional support for abnormal laboratory test results.

· Leading analytical method transfers to the lab following ownership of MSAT

· Participate in laboratory-related projects and support their implementation within the laboratory.

· Ensuring analytical methods are validated according to regulatory guidelines

· Coordinating the execution of analytical validation/transfers protocols to ensure it is performed according to the committed scheduled plan

· Performing periodically trend analysis on method performance to determine the need to revalidate, optimize, or replace the method

· Providing technical expertise and troubleshooting support for analytical methods

· Writing and maintaining accurate analytical methods procedures and analytical validation master plan, protocols, and reports

· Training quality control staff on new analytical methods and lab instruments and automation.

· Ensuring all activities comply with regulatory requirements (e.g., FDA, EMA)

· Conducting risk assessments related to analytical methods and lab instruments/automation

· Evaluating and recommending new state-of-the-art technologies and methods to enhance quality control activities, with a strong relationship with MSAT and R&D

· Supporting QC teams during internal and external audits and inspections

· Performing regulatory surveillance to stay updated on industry trends and regulatory changes to ensure ongoing compliance (incl. Pharmacopoeia)

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!