GMP审计员 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
  • 专业培训
  • 年终奖金
  • 定期体检

职位描述

Responsibility:职责GMP AUDIT ( approx. 60% of job duty)1)To prepare and perform GMP audit to pharmacetical companies: APIs, primary packaging materials and excipients producers.准备并执行GMP审计，审计对象为制药行业APIs、内包材以及辅料生产商。2)Preprare audit report in English以英语为工作语言准备审计报告3)CAPA follow upCAPA跟进GMP CONSULTING (approx. 40% of job duty)1)To provide GMP related technical consultancy service to pharmaceutical industry customers, which includes: implementation of Quality Management System, development of data integrity policy, training courses, etc.为制药行业的客户提供GMP相关技术咨询服务，包括：实施质量管理体系、开发数据可靠性策略、培训等。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 pharmaceutical organization for GMP compliance or similar至少5年以上GMP符合性或类似部门的工作经验iii.At least 3 years working experience in GMP audit至少3年以上GMP审计经验iv.Project management experience is preferred.有项目管理经验优先i.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。ii.Good understanding and communication skills良好理解及沟通能力iii.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： 审计 GMP质量 验证 咨询 质量体系

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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