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M&S-QA Specialist-Hangzhou

Synthorx

Synthorx

Quality Assurance
Hangzhou, Zhejiang, China
Posted 6+ months ago

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 broaden global view sight

What you can contribute?

  • 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;

  • 管理 GMP 受控文件和记录,确保文件和记录的修订,发放,存档,收回和销毁符合程序规定;

Management of controlled GMP documents and records, assure documentation and record revise, distribution, archival, retrieve and destroying compliance to established procedure.

  • 依据总部计划负责文件管理系统的更新和测试;

Responsible for document management system update and test implementation according to global requirements

  • 负责文件管理系统用户培训;

Responsible for provide training to user

  • 管理Artwork设计审批流程符合程序规定;

Management of Artwork design and review compliance to established procedure.

  • 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.

  • 执行指定的质量流程评估,制定所需的改进措施;

Implement assessing for specific quality processes, making remediation actions.

  • 支持CAPA管理体系;

Support for management of CAPA system.

  • 支持指定的质量成熟度指数(QMI)及质量体系标准的评估。

Support with designated Primary Process Owner (PPO) for the assigned Quality Maturity Index (QMI)/Quality System Standard.

  • 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.

  • 支持相关部门一起参与偏差、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;

  • 负责商务部门协作和需求文件准备。

Responsible for coordinating with commercial department and preparing the related documents

  • 上级领导安排的其他工作。

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.

  • 以往没有写明,但应该体现在其他岗位中的重要职责。

The important responsibilities should be added in other position which didn’t be stated past。

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: 3年以上相关工作经验

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 three year quality management or production work experience in Pharmaceutical company, especially in foreign enterprise work experience (在药厂超过3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

(PTW 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

If you want to be part of a team that puts patients first, plays to win in digital era with courage, integrity, respect and trust, to inspire your own career journey through a care & collaborate platform, and with special focus on below competency:

  • Exercise good judgment & drives change for competitive advantage
  • Drive for superior results & has passion to win
  • Build the talent pipeline and develop others
  • Able to burden pressure, result driven

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.