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WA
文件管理QA(J23419)
WuXi AppTec · 江苏省·无锡市
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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