高级项目工程师 上海

月薪： 0.5-1.5万/月

该公司所有职位
  • 5-7年经验
  • 本科
  • 招1人
  • 01-10 发布
  • 五险一金
  • 补充医疗保险
  • 补充公积金
  • 通讯补贴
  • 年终奖金
  • 定期体检
  • 专业培训

职位描述

1.To provide GMP related technical consultancy service to pharmaceutical industry customers.为制药行业的客户提供GMP相关技术咨询服务。2.Be responsible for projects on GMP compliance of drug products, APIs, primary packaging materials and excipients, which includes: Computerized Systems Validation, Process validation, Cleaning Validation, Analytical Method Validation, Facilities & Equipment Commissioning and Qualification, etc.负责制剂、API、内包材以及辅料的GMP符合性项目，包括：计算机系统验证、工艺验证、清洗验证、分析方法验证、厂房&设备试运行与确认等。3.Be responsible for projects to implement Quality Systems according to GMP requirements.负责GMP质量体系实施项目。4.To provide GMP training courses to customers.为客户提供GMP培训课程。5.Be responsible for other technical areas/projects regulated by GMP.负责其他GMP相关技术领域的咨询项目。Requirements:要求i.Chemical Engineer, Chemist or Pharmacy with bechlor degree and above化学工程师、化学或药学专业本科及以上ii.At least 5 years working in organization under GMP compliance or similar, work experience in computerized systems validation is preferred至少5年以上GMP符合性或类似部门的工作经验，有计算机系统验证经验者优先iii.Project management experience is preferred.有项目管理经验优先iv.Fluent written and oral English. Be able to keep fluent communicate with English speaking colleagues; be able to prepare all technical documents in English英语口语流利，书面英语良好。能用英语与西班牙同事沟通；能以英语准备所有技术文件。v.Good understanding and communication skills良好理解及沟通能力vi.Available for short term business trip能适应短期出差 职能类别： 药品生产/质量管理 药品注册 关键字： 项目管理 GMP质量 验证 培训 咨询

联系方式

万航渡路888号开开广场13楼K座

公司信息

TDV is a Spanish Company, with headquarter located in Barcelona, Spain and branch company located in Shanghai. TDV is a leading company in technological and regulatory consultancy for the pharmaceutical and chemical-pharmaceutical fields especially in quality and regulatory aspects (GMP, GLP, GCP). We provide professional services including: GMP audits, preparation of regulatory documentation(DMF, CEP,…), preparation of US FDA and EU regulatory inspections, training services, design and qualification of facilities, process validation, computerised systems validation,…to our international customers in EU, Asia…TDV是一家西班牙企业，总部位于西班牙巴塞罗那。上海韬维医药咨询有限公司为其子公司。TDV在制药和化学领域的技术和法规咨询服务处于行业领先地位，尤其是质量和法规方面，包括GMP、GLP、GCP。公司为国际客户（包括欧洲、亚洲等）提供的专业服务包括： GMP审计、编写法规文件(DMF、CEP等)、备战US FDA和EU法规检查、培训服务、厂房设计与确认、工艺验证、计算机化系统验证等。

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