Quality Leader/QMR

Found in: beBee S CN - 3 weeks ago


Suzhou, China bioMérieux Full time

质量保证/Quality Assurance

 

  1. 建立和发展质量保证团队,确保所有QA相关流程的良好实施,包括产品发布,CAPA,变更控制,NCMR,开发,Rework等。
    Establish and Develop quality assurance team to ensure all QA related processes are well implemented, including product release, CAPA, Change Control, NCMR, Dev, Rework and etc.
  2. 定期向上级报告关键质量问题
    Periodically report provided to superior for key quality issues
  3. 担任转移项目的质量代表来支持团队实施项目转移
    Acting as quality representative for transfer project to support team for transfer implementation.
  4. 根据内部客户反馈或其他BMX站点的基准,继续改进QA相关流程。
    Continue improve QA related process based on internal customer feedback or benchmark with other BMX sites.
  5. 负责苏州工厂生产产品的工厂放行

Responsible for product release in BSuB site

 

验证/Validation

 

  1. 制定并执行项目资质计划,包括但不限于设备、设施、公用设施、工艺及方法等。

Establish and execute project qualification plan including but not limited to equipment ,facility, utility, process, method and so on.

  1. 协调和监管内外部验证活动。
    Coordinate and Supervise the internal and external validation activities.
质量控制/Quality Control  
  1. 负责质量控制程序的制定和实施,包括来料检验、半成品检验、成品检验、稳定性检验、OOS调查等。
    Responsible for activities engaged in quality control procedure establishment, implementation including in-coming testing, semi-finished testing, finished goods testing, stability testing, OOS investigation and so on.
  2. 负责环境监测;
    Responsible for environment monitoring,
  3. 负责校准程序
    Responsible for Calibration program
  4. 负责抽样计划的制定和实施
    Responsible for sampling plan establishment and implementation 
  5. 支持产品性能研究和相关测试。
    Support product performance study and related testing.
  6. 在QC实验室实施良好的实验室规范
    Implement good laboratory practices in QC lab

 

质量体系管理/QMS

 

  1. 负责质量体系的建立和提高

Responsible for QMS establishment and improvement

  1. 负责文件控制和记录管理

Responsible for document control and record management

  1. 负责内审执行和外审协调来保证系统符合合适的法规及标准

Responsible for internal audit implementation and external audit coordinate to ensure the system is consistently complying to applicable standards and regulations

  1. 负责供应商相关的质量管理,包括新供应商确认,供应商质量问题处理等等

Responsible for Supplier related quality management including new supplier qualification, supplier quality issue handling and so on

 

其他Others  
  1. 密切监控法规的演变,实施差距分析,并跟进缓解计划的实施
    Closely monitor regulation evolvement, implement gap analysis and follow up on mitigation plan implementation 
  2. 负责QA/QC团队的管理
    Responsible for QA/QC team management

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