岗位职责:

负责公司GMP文件管理，主要包括:

Responsible for management of company GMP procedure documents, mainly including:

1、程序文件的分发、收回、销毁和存档等;

Distribute, withdraw, discard and archive the procedure documents.

2、管理部门文件管理员;

Manage the Department Document Administrator.

3、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.

4、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.

5、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.

6、负责维护工厂质量协议数据库

Maintain the Site QAA database.

7、完成主管安排的其他工作和任务

Any jobs and responsibilities assigned by the line manager.

任职要求:

1、大专及以上学历。

College degree or above

2、熟悉GMP相关法规

Familiar with GMP regulations

3、基础英文阅读理解能力

Basic ability of English reading comprehension.

4、熟悉MSOffice办公软件

Familiar with MSOffice

5、一年以上文件管理相关工作经验

Minimum 1 year of experience in documentation management.

6、具有良好的协调沟通能力

Good skills of coordination and communication.

7、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.

8、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.