崗位職責(zé):
負(fù)責(zé)公司GMP文件管理,主要包括:
Responsible for management of company GMP procedure documents, mainly including:
1、程序文件的分發(fā)、收回、銷毀和存檔等;
Distribute, withdraw, discard and archive the procedure documents.
2、管理部門文件管理員;
Manage the Department Document Administrator.
3、審核程序文件格式,跟蹤程序文件的培訓(xùn)進(jìn)程,維護(hù)文件數(shù)據(jù)庫,跟蹤程序文件的定期回顧;
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、控制部門表格/日志,包括分發(fā)和舊版回收等;
Control the forms/logbooks, including distribution and old version recall, etc.
5、維護(hù)工廠文件記錄索引; 管理文件的存檔和借閱
Maintain the Site Documents Index. Manage documents archiving and borrowing.
6、負(fù)責(zé)維護(hù)工廠質(zhì)量協(xié)議數(shù)據(jù)庫
Maintain the Site QAA database.
7、完成主管安排的其他工作和任務(wù)
Any jobs and responsibilities assigned by the line manager.
任職要求:
1、大專及以上學(xué)歷。
College degree or above
2、熟悉GMP相關(guān)法規(guī)
Familiar with GMP regulations
3、基礎(chǔ)英文閱讀理解能力
Basic ability of English reading comprehension.
4、熟悉MSOffice辦公軟件
Familiar with MSOffice
5、一年以上文件管理相關(guān)工作經(jīng)驗(yàn)
Minimum 1 year of experience in documentation management.
6、具有良好的協(xié)調(diào)溝通能力
Good skills of coordination and communication.
7、能夠與團(tuán)隊(duì)協(xié)同工作,跨部門合作和自我管理
Good skills of co-working, cross-department collaboration and self-management.
8、能夠在一定的壓力下工作,在規(guī)定的時(shí)間交付工作
Ability to work under pressure and deliver work achievement on time.