Job title职位名称: Qualification & Validation Supervisor

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 Qualification & Validation Supervisor 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：

• Implementing and maintaining qualification and validation strategies, plans,

protocols, and reports, in collaboration with internal and external stakeholders

• Maintaining and updating the validation master plan and procedures, and

ensuring alignment with the company's quality management system

• Ensuring the compliance of qualification and validation with applicable regulatory requirements and company quality standards

• Maintaining a system to ensure compliance and quality risks are properly

identified, tracked, and mitigated

• Ensuring the proper documentation, review, and approval of qualification and

validation deliverables, such as risk assessments, traceability matrices, test

scripts, deviations, and summary reports

• Ensuring that all equipment and facilities are properly qualified and validated

• Overseeing the execution of qualification and validation studies

• Establishing metrics and monitoring data for the qualification and validation

activities, to identify trends and issues and to conduct periodic reviews and re-

validation as necessary.

• Establishing and monitoring key performance indicators(KPIs) and metrics for the qualification and validation, and report on the qualification and

validation performance and effectiveness

• Promoting a culture of quality throughout the organizations (e.g., engineering,

MSAT, operations) involved in qualification and validation activities

• Identifying and driving continuous improvement initiatives and projects to

enhance the qualification and validation efficiency and effectiveness fostering a

culture of continuous improvement

• Evaluating and recommending new technologies, tools, and methods to enhance qualification and validation processes and outcomes

• Leading management reviews to assess the effectiveness of the qualification and

validation activities

• Leading and managing the qualification and validation team, including hiring,

training, coaching, professional development, and performance evaluation.

• Quality qualification and validation representative in Q&V projects for new and

existing equipment and facilities within the defined scope

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 5 years’ experience in quality system validation QA area. M

至少药学或生物学相关专业大学本科及以上学历，至少5年质量体系验证QA经验。

•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.

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!