北京 [切换城市] 北京招聘北京生物/制药/医疗器械招聘北京医药技术研发人员招聘

AS Project Lead- 实验室分析方法项目主管

职位信息

  • 发布日期:2013-09-18
  • 工作地点:北京
  • 招聘人数:1
  • 工作经验:三年以上
  • 学历要求:硕士
  • 语言要求:英语良好
  • 职位类别:药品生产/质量管理  医药技术研发人员

职位描述

1. Ensure that all activities are performed according to the local Quality system and SOP’s.
确保所有行为均符合本厂质量体系和SOP的要求。
2. Ensure the timely testing and release of materials/products/ samples/projects and to ensure that all aspects of the operational business comply with cGMP legal and regulatory requirements and with the Novartis Pharma Corporate Quality Manual and Policies.
确保物料/成品/样品/项目及时地检验并放行,确保所有操作均符合cGMP的法律法规和诺华公司质量手册及相关政策的要求。
3. Support the development and/or improvement of existing analytical test methods used in the Quality Control Laboratories.
协助质量控制实验室完成分析方法的开发及优化工作。
4. Based on request from Quality Control Laboratories, review and evaluate proposed changes to local, global and pharmacopoeia test procedures that impact on the laboratory and to provide input to the finalised documents. Complete corresponding method validation or verification.
基于质量控制实验室的要求,审核和评估本地、全球和药典检测过程的改变对本地实验室的影响,提供最终文件,并完成相应的方法验证和确认。
5. Co-ordinate and participate in analytical method transfer activities associated with new product launches and marketed product site transfers.
协助并参与有关新产品推出和上市产品产地转移的分析方法转移。
6. Provide analytical testing and sampling support for production equipment cleaning validation activities if necessary.
在必要的情况下为生产仪器清洁验证分析检查和抽样提供支持。
7. Provide specialised analytical testing support and/or manage contract laboratory support of product investigations as well as Technical Support initiatives.
为产品调查提供分析技术支持和协调合作实验室的支持工作。
8. Follow HSE regulations and site related SOP. Perform good behavior-based safety.
遵守健康、安全、环境法则和工厂相关的标准操作规程,履行正确的行为安全。

公司介绍

Pharma operation - 北京诺华制药有限公司 北京昌平制药工厂诚聘

联系方式

  • Email:chen.li@novartis.com