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A Range of Possibilities

Specialist, Qualification & Validation

date posted 04/22/2019
contract type Full time
job id R2498604
location Shenzhen, China

关键职责:

合规和日常管理

  • 协调工厂的验证活动,审核验证方案/报告。为验证活动提供技术支持,执行验证活动的现场监控,确保所有验证活动的执行符合cGMP,既定的策略和总部的标准。
  • 参与与验证相关的偏差调查,以及CAPA的制定。
  • 起草验证体系内的技术操作规程,同时执行总部相关文件与工厂本地文件的差距分析。
  • 在工厂范围内组织、提供技术培训,以提高整体验证能力。
  • 与总部的验证团队和Q&V CoP保持良好的沟通,以确保工厂的验证流程,原则和标准与总部的要求保持一致。
  • 确保工作场所内所有的活动遵从HSE8的要求。
  • 在日常工作中遵从成本控制。

人员和文化建设

  • 保持与质量体系、现场质量团队以及其它部门的良好沟通/合作,了解客户需求,建立信任。
  • 参与工厂质量文化建设和维护。
  • 践行工厂正直、尊重、勇气、合作的价值观。

其它

  • 验证主管/QA经理安排的其它工作。

职位要求:

1.大学本科以上学历,生物、化学、药学等相关专业。

2.1-3年制药行业相关经验,生物制药优先。

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.

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Please note you are leaving the corporate site of Sanofi and are being redirected to our applicant tracking system, Workday, which allows you to apply to our open positions.

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