Companies you’ll love to work for

Correlation Ventures

M&S-Senior Validation Supervisor-Hangzhou



People & HR, Operations
Hangzhou, Zhejiang, China
Posted on Monday, November 13, 2023

Who we are?

As a global healthcare leader and a Global Top Employer, we are as much a partner to patients facing health challenges as we are a partner to you on your career journey. We are focused on empowering our people to be agents of change, because the work we do will change health outcomes and empower patients’ lives. This is where you will have access to a broad track for all-round development as well as the platform to work as one team across one of the broadest healthcare and well-being portfolios globally.

Why start your career path in Sanofi?

Here, you can:

- Set clear direction & aligns team & others, around common objectives

- Inspire continuous improvement & breakthrough thinking,display analytical &conceptual thinking

- Have broad presence and resources within large platform to boarden globlal view sight

What you can contribute?

  • 负责验证体系的维护和改进
  • Responsible for validation systems maintenance and improvement
  • 建立和定期更新验证主计划,并根据VMP追踪验证的实施情况
  • Prepare and update site validation master plan and tracing validation execution status in terms of VMP.
  • 验证支持和URS/验证文件的审核
  • Validation support and URS/ validation document review
  • 在验证的标准操作程序中定义验证的策略,职责和验证的文件,确保验证符合中国和欧盟GMP要求和总部的质量要求。
  • Define the strategy; responsibility and document of the validation in the standard operation procedure to ensure that validation comply with the Chinese GMP and EU GMP requirement and global quality requirement.
  • 组织协调相关部门进行验证活动 .
  • Organize with the related department to perform validation activities
  • 审核验证文件并参与以下的验证活动:
  • Review validation document and participate in the validation activities below
  • 生产工艺验证(包括存放周期验证)
  • Process validation (include bulk holding time validation)
  • 设备验证(包括生产设备、公用系统和实验室设备)
  • Equipment qualification (include manufacture equipment , utility , facility and QC instrument)
  • 分析方法验证
  • Analytical method validation
  • 计算机控制系统验证
  • Computerized system validation
  • 清洁验证
  • Cleaning validation
  • 运输验证等
  • Transportation validation and so on
  • 负责清洁验证的执行和实施,协调供应链,生产和QC部门配合完整清洁验证活动。
  • Be responsible for the conduction and execution for cleaning validation, coordinate the PSC , production and QC to achieve the activity together.
  • 配合上游工厂完成相关的运输验证活动,完成阶段性的运输验证报告,支持杭州工厂中间体的放行工作。
  • Coordinate the upstream site to complete the shipping validation, and finish the interim report to support the release of IPC in Hangzhou site.
  • 负责欧盟产品的运输验证和运输风险评估工作
  • Be responsible for shipping validation and risk assessment of EU production.
  • 负责质量部项目涉及的验证和确认的管理,如新厂房,公用系统等。确保项目的验证工作的GMP 符合性。
  • Take the responsibilities for projects on validation & qualification of the quality department,Such as new premise and new HVAC. Ensure the implementation of GMP readiness part of the project.
  • 作为实验室计算机化设备(色谱系统)的实验室管理员进行日常的管理(权限回顾,系统配置设置等)
  • Take the responsibility oflab computerised equipment(Empower system) manager for the routine management.(review for access control , Empower system configuration.)
  • 作为审计专家, 组织和参与工厂内部和供应商的审计工作。
  • As a audit leader expert , organize and take part in the audit, including Hangzhou site and supplier.
  • Other assignments.
  • 领导安排的其它工作;
  • Be accountable for providing a safe work environment and maintaining HSE performance for his/her area and activities.
  • 对自己职责范围内职业健康安全环境工作全面负责。
  • ​The designated Primary Process Owner (PPO) is responsible for the assigned Quality Maturity Index (QMI)/Quality System Standard.
  • 负责指定的质量成熟度指数(QMI)及质量体系标准。
  • PPO is responsible for assessing quality processes, review assessment and making remediation actions with the Site Leadership Team;
  • 负责质量流程评估,与工厂管理层一起审核评估结果并制定所需的改进措施;

What you should have?

Education / Experience

Must have: 最低要求

Education教育: University (本科)

Professional /Major专业: Pharmacy or experience in related area


Experience 经验: N/A

Better to have: 优先考虑项

Education教育: Postgraduate (研究生)

Professional /Major专业:Pharmacy or related field (药学或相关领域)

Experience 经验: More than five years validation work experience in Pharmaceutical company, prefer foreign enterprise work experience (在药厂超过五年的验证的工作经验,特别是在外企的工作经验

Technical skills & Competencies / Language

Must have : 最低要求

Technical 技能: N/A

Language语言: English reading and writing (能使用英语阅读和书写)

IT Skill电脑技能: office software(熟练应用办公电脑软件)

Other Ability其他能力: Team work spirit (团队工作的精神)

Better to have : 优先考虑项

Technical 技能: Familiar to cGMP (熟悉现行GMP)

Language语言: Good at English reading, writing, listening and speaking(良好的英语听、说、读、写能力)

IT Skill电脑技能: Senior(高级)

Other Ability其他能力:Good communication and transversally cooperation(良好的沟通协调能力)

Behavioural Competencies (LEAD and others)

Must to have : 最低要求

  • Stretch to beyond 超越自我
  • Take action 主动出击
  • Patients Focus 患者为中心
  • One Sanofi 组织为先

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.