M&S-Senior Validation Supervisor-Hangzhou
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?
- Responsible for validation systems maintenance and improvement
- Prepare and update site validation master plan and tracing validation execution status in terms of VMP.
- Validation support and URS/ validation document review
- 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
- Review validation document and participate in the validation activities below
- Process validation （include bulk holding time validation）
- Equipment qualification (include manufacture equipment , utility , facility and QC instrument)
- Analytical method validation
- Computerized system validation
- Cleaning validation
- Transportation validation and so on
- Be responsible for the conduction and execution for cleaning validation, coordinate the PSC , production and QC to achieve the activity together.
- Coordinate the upstream site to complete the shipping validation, and finish the interim report to support the release of IPC in Hangzhou site.
- 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.
- 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.
- Be accountable for providing a safe work environment and maintaining HSE performance for his/her area and activities.
- The designated Primary Process Owner (PPO) is responsible for the assigned Quality Maturity Index (QMI)/Quality System Standard.
- PPO is responsible for assessing quality processes, review assessment and making remediation actions with the Site Leadership Team;
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.