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文件管理QA(J23419)

WuXi AppTec · 江苏省·无锡市

External listingFull-time7 months ago

About The Role

负责公司GMP文件体系管理,主要包括

Responsible for management of company GMP procedure documents, mainly including

  •  质量体系文件的维护和持续改进
  • Maintain and continuously improve the quality system documents.
  •  程序文件的分发、收回、销毁和存档等;
  • Distribute, withdraw, discard and archive the procedure documents.
  •  管理部门文件管理员;
  • Manage the Department Document Administrator.
  •  审核程序文件格式,跟踪程序文件的培训进程,维护文件数据库,跟踪程序文件的定期回顾;
  • Review the format of procedure document, track the training progress of procedure documents and maintain the document database, follow up the regular review of procedure documents.
  •  控制部门表格/日志,包括分发和旧版回收等;
  • Control the forms/logbooks, including distribution and old version recall, etc.
  •  维护工厂文件记录索引; 管理文件的存档和借阅
  • Maintain the Site Documents Index. Manage documents archiving and borrowing.
  •  完成主管安排的其他工作和任务
  • Any jobs and responsibilities assigned by the line manager.
  • 大专及以上学历。
  • College degree or above
  • 熟悉GMP相关法规
  • Familiar with GMP regulations
  • 基础英文阅读理解能力
  • Basic ability of English reading comprehension.
  • 熟悉MSOffice办公软件

Familiar with MSOffice

  • 一年以上文件管理相关工作经验
  • Minimum 1 year of experience in documentation management.
  •  具有良好的协调沟通能力
  • Good skills of coordination and communication.
  •  能够与团队协同工作,跨部门合作和自我管理
  • Good skills of co-working, cross-department collaboration and self-management.
  •  能够在一定的压力下工作,在规定的时间交付工作
  • Ability to work under pressure and deliver work achievement on time.

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