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M&S-QA Supervisor-Hangzhou

Synthorx

Synthorx

People & HR, Operations, Quality Assurance
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?

  • 第三方管理:建立供应商管理程序;管理供应商档案;安排供应商/合同商的审计;起草质量协议;对已批准的供应商质量进行监督和评估;对供应商进行审计;审核物料质量信息。
  • Management of third parties: establish the procedure for the third party management, which includes management of the supplier profile, audit arrangement of the suppliers/contractor, establishment of quality agreement, and administration and evaluation of the quality of the authorized suppliers. Implement the audit to third parties. Review the material quality information.
  • 与集团内部工厂沟通生产过程中所识别的物料缺陷;起草并协调集团内部供应商质量协议的签订。
  • Communicate with internal site for the related material defect identified in the site manufacturing. Draft and coordinate the signature of quality agreement with internal sites.
  • 对总部文件和中国法规进行差距分析,确保质量体系符合现行GMP和赛诺菲总部要求;
  • Conduct gap analysis for Chinese regulation and global documents, ensure quality system compliance to CGMP and Sanofi global requirement;
  • QSMP 维护(起草,更新,存档)
  • Maintenance of QSMP. Including drafting, updates, and archiving.
  • 供应商变更信息跟进,供应商和承包商清单更新
  • Follow up supplier change information. Update the list of supplier and contractor.
  • 负责数据完整性管理和数据完整性在工厂的布署:培训和记录的持续改善。
  • Responsible data integrity management, deploy data integrity into site. Include training and continual improvement for record.
  • 实验室数据完整性的审核 lab data integrity audit
  • QC日常符合性巡查和监督,确保现场操作符合现行GMP和程序要求。执行月度产品放行前的审计追踪检查
  • Carry out the routine inspection and administration of QC compliance, ensure that activities in QC with what are required by cGMP and procedures. Carry out the audit trail inspection before products release monthly
  • 根据集团文件或官方等要求,起草或更新相关的文件;
  • As per the requirement from global document or regulatory authority etc., create or update the related SOPs.
  • 负责指定的质量成熟度指数(QMI)及质量体系标准的维护和更新。
  • Responsible for specific Quality Maturity Index (QMI)/Quality System Standard maintenance and updating.
  • 作为PPO负责指定质量流程的评估,与工厂管理层一起审核评估结果并制定所需的改进措施;
  • As specific PPO is responsible for assessing quality processes, review assessment and making remediation actions with the Site Leadership Team;
  • 致力于提高对质量流程的自我认知力,并从而推动相关质量体系的成熟度的持续提升。
  • The aim is to drive self-awareness of the quality process and drive the improvement of the maturity of the respective quality system.
  • 同其它部门一起参与偏差、OOS、OOT和投诉的调查,并落实整改措施;
  • Take part in deviations, OOS, complaints investigation with other department and follow up CAPA;
  • 领导安排的其它工作;
  • Conduct boss assigned other works.
  • 对本岗位的职业健康安全环境工作负责。
  • For Employees(员工): Be responsible for HSE in his/her position and job.

What you should have?

Education / Experience

Must to have :最低要求

Education教育: University (本科)

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

Experience 经验: NA

Better to have : 优先考虑项

Education教育: Postgraduate (研究生)

Professional /Major专业:Pharmacy (药学)

Experience 经验: More than five year quality management or production work experience in Pharmaceutical company, especially in foreign enterprise work experience (在药厂超过五年的质量管理或生产的工作经验,特别是在外企的工作经验)

Technical skills & Competencies / Language

Must to have : 最低要求

Technical 技能: work hard and carefully, good at learning new things(工作仔细认真,善于学习新事物)

Language语言: Have the ability of reading and writing in English (能使用英语阅读和书写)

IT Skill电脑技能: Familiar to 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.