工作內(nèi)容 Work Content
1.檔案室的管理Archive Management
1.1 負(fù)責(zé)檔案室的文件管理。Responsible for the management of the archives room.
1.2 維護(hù)QA檔案室文件清單。Responsible for maintaining the Document List in QA Archives.
1.3 負(fù)責(zé)檔案室的溫濕度記錄和維護(hù)。Responsible for recording and maintaining the temperature and humidity of the archives room.
2. 文件的管理 Management of Document and File
2.1 按照SOP要求對(duì)GMP文件進(jìn)行接收、登記、復(fù)印、分發(fā)、收回、借閱、作廢、銷毀。Receive, register, copy, distribute, recall, lend, obsolete and destruct GMP document according to SOP requirements.
2.2 負(fù)責(zé)本部門文件、檔案的借閱登記，保管工作。Responsible for lending, registering and archiving the documents and
files in QA department.
3. 分析文件的管理 Management of Analytical Document
3.1 嚴(yán)格按照SOP對(duì)GMP分析文件進(jìn)行接收、登記、復(fù)印、分發(fā)、收回、借閱、作廢、銷毀。Receive, register, copy, distribute, recall, lend, obsolete and destruct GMP analytical document exactly according to SOP.
3.2 負(fù)責(zé)分析文件電子存檔的管理工作。Manage electronic documentation for analytical documentation.
4. 記錄管理Record Management
4.1 負(fù)責(zé)QA控制記錄模板的發(fā)放、登記、回收、存檔借閱等工作。Responsible for the issuance, registration, recovery and archiving of QA control records template.
4.2 監(jiān)督記錄的變更應(yīng)符合程序要求，與記錄相關(guān)的偏差應(yīng)及時(shí)報(bào)告和處理。Supervise that the change for record is compliant with requirement; deviation related with record should be reported and handled on time.
4.3 定期對(duì)各種文件、記錄進(jìn)行整理、核對(duì)。Organize and check all the documents and records at regular intervals.
4.4 負(fù)責(zé)外印記錄的管理。Responsible for the management of externally printed records.
5. 培訓(xùn)管理 Training Management
5.1 制定QA部門的季度培訓(xùn)計(jì)劃和年度培訓(xùn)計(jì)劃，對(duì)培訓(xùn)計(jì)劃執(zhí)行情況進(jìn)行跟蹤。Make the quarter training plan and annual training plan of QA department, follow up the implementation of the training plan.
5.2 審核整理保存其他部門的員工檔案，部門季度培訓(xùn)計(jì)劃等。Review, organize and save employee files, departmental quarter training plan etc.
5.3 組織各部門的課堂培訓(xùn)和新員工入職的GMP培訓(xùn)。Organize classroom training of all departments and GMP training for new employees.
5.4 負(fù)責(zé)培訓(xùn)效果評(píng)估的管理。Responsible for the management of training effectiveness evaluation.
5.5 負(fù)責(zé)培訓(xùn)講師的管理。Responsible for the management of trainer.
6. DMS系統(tǒng)管理DMS System Management
6.1 負(fù)責(zé)參與DMS系統(tǒng)的驗(yàn)證相關(guān)工作。Participate in the DMS system validation.
6.2 作為部門文件管理員，參與DMS系統(tǒng)的管理。As the department document manager, participate in the management of DMS system.
7. TMS系統(tǒng)管理 TMS System Management
7.1 負(fù)責(zé)參與TMS系統(tǒng)的驗(yàn)證相關(guān)工作。Participate in the TMS system validation.
7.2 作為部門培訓(xùn)專員，參與TMS系統(tǒng)的管理。As the department training manager, participate in the management of TMS system.
8. QMS系統(tǒng)管理 QMS System Management.
8.1 負(fù)責(zé)參與QMS系統(tǒng)的驗(yàn)證相關(guān)工作。Participate in the QMS system validation.
8.2 作為QA部門QMS系統(tǒng)SME，參與QMS系統(tǒng)的管理。As the QMS system SME in QA department, participate in the management of QMS system.
9. CAPA管理CAPA Management
9.1 負(fù)責(zé)在QMS系統(tǒng)中CAPA計(jì)劃的批準(zhǔn)。Responsible for the approval of the CAPA plans in QMS system.
9.2 負(fù)責(zé)在QMS系統(tǒng)中CAPA實(shí)施結(jié)果的批準(zhǔn)。Responsible for approving the implementation results of CAPA in QMS system.
9.3 負(fù)責(zé)在QMS系統(tǒng)中CAPA延期、修訂、撤銷的管理。Responsible for managing the extension, revision, and withdrawal of CAPA in QMS system.
9.4 負(fù)責(zé)在QMS系統(tǒng)中CAPA有效性評(píng)估的批準(zhǔn)。Responsible for approving the effectiveness evaluation of CAPA in QMS system.
10. 變更管理 Change Management
10.1 負(fù)責(zé)文件、培訓(xùn)、蟲害控制等相關(guān)變更的審核。Responsible for reviewing related changes in documents, training,
pest control, etc.
10.2 負(fù)責(zé)變更發(fā)號(hào)及歸檔。Responsible for issuing change numbers and archiving changes.
11. 蟲害控制管理 Pest Control Management
11.1 負(fù)責(zé)蟲害控制綜合防制方案的批準(zhǔn)。Responsible for approving the comprehensive pest control prevention
and control plan.
11.2 負(fù)責(zé)蟲害控制月度報(bào)告的批準(zhǔn)。Responsible for approving the monthly pest control report.
11.3 負(fù)責(zé)蟲害控制年度報(bào)告的批準(zhǔn)。Responsible for approving the annual pest control report.
12. 設(shè)備驗(yàn)證管理 Equipment Validation Management
12.1負(fù)責(zé)設(shè)備驗(yàn)證和確認(rèn)的相關(guān)文件審核和批準(zhǔn)。Responsible for review and approval of equipment validation and
qualification documents.
12.2 審核和批準(zhǔn)設(shè)備驗(yàn)證和確認(rèn)相關(guān)的變更。Review and approve the equipment validation and qualification
related change control.
13. 負(fù)責(zé)法規(guī)月度查新。Responsible for monthly regulatory surveillance.
14. 負(fù)責(zé)客戶調(diào)查問卷的填寫。Responsible for filling out the customer questionnaires.
15. 負(fù)責(zé)質(zhì)量協(xié)議的審核及管理。Responsible for the review and management of quality agreements.
16. 負(fù)責(zé)訪問權(quán)限的管理。Responsible for the access control management.
17. 負(fù)責(zé)內(nèi)部審計(jì)和外部審計(jì)的文件準(zhǔn)備和管理。Responsible for the internal and external audit document preparation
and management.
18. 完成本部門領(lǐng)導(dǎo)臨時(shí)安排的工作。Complete any interim arrangements arranged by the leadership of the department.t.

教育背景和任職資格 Education Background And Qualification
1.教育背景Education Background: 制藥、英語、科技英語或其他相關(guān)專業(yè)本科及以上學(xué)歷，碩士學(xué)歷優(yōu)先。Education: A bachelor's degree or above in Pharmaceutical English, Scientific English or other related majors, Master degree is a plus.
2.工作經(jīng)驗(yàn)：5年以上制藥行業(yè)體系QA和文件QA的工作經(jīng)驗(yàn)，2~3年管理團(tuán)隊(duì)的經(jīng)驗(yàn)。