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工作內(nèi)容 Job Description 1. 學(xué)習(xí)《藥品生產(chǎn)質(zhì)量管理規(guī)范》對機(jī)構(gòu)與人員、文件管理的要求，以協(xié)助部門負(fù)責(zé)人負(fù)責(zé)文件和培訓(xùn)工作；Learn “Good Manufacturing Practice” requirements for Institutions, personnel and document management to assist the department head in the documentation management and training work. 2. 管理組內(nèi)的工作并解決工作中的問題；Responsible for managing the work assigned to the team and solving work problems. 3. 負(fù)責(zé)與相關(guān)部門團(tuán)隊協(xié)調(diào)溝通，將工作任務(wù)進(jìn)行合理分配；Responsible for communicating with relevant department and team, assign work reasonably. 4. 負(fù)責(zé)GMP 文件統(tǒng)一編號的管理；Responsible for the management of GMP document numbering. 5. 負(fù)責(zé)紹興廠區(qū)的SOP 管理；Responsible for SOP management of Shaoxing Site. 6. 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. 7. 負(fù)責(zé)編制文件和檔案的管理目錄；Responsible for preparing the list of document and file. 8. 負(fù)責(zé)文件接收、發(fā)放、登記、分類、歸檔等的管理；Responsible for receiving, distributing, registering, classifying, archiving of document. 9. 負(fù)責(zé)客戶文件的登記、存檔管理；Responsible for the registering, archiving of client document. 10. 如接收文件等不符合要求的立即報上級領(lǐng)導(dǎo)；Report to superior if the received document can not meet the requirement. 11. 負(fù)責(zé)新員工GMP 意識培訓(xùn)，本部門培訓(xùn)工作及紹興公司各部門培訓(xùn)文件管理；Responsible for GMP awareness training for new employees, managing the training of QA department and the training documents of each department. 12. 負(fù)責(zé)編制本部門年度培訓(xùn)計劃，整理培訓(xùn)記錄，定期考核培訓(xùn)效果、完成培訓(xùn)總結(jié)；Responsible for the preparation of the annual training plan, organizing training records, assessment of the training effectiveness and completing training summary. 13. 負(fù)責(zé)編制GMP 和質(zhì)量相關(guān)的培訓(xùn)資料，協(xié)助部門負(fù)責(zé)人對公司全員開展 GMP 培訓(xùn)；Responsible for the preparation of GMP and quality-related training materials, and assist to carry out GMP training for staff. 14. 負(fù)責(zé)編制GMP 和質(zhì)量相關(guān)的考核試卷，組織公司全員GMP 考核；Responsible for the preparation of GMP and quality related examination papers, organizing GMP assessment for all personnel. 15. 督促其他GMP 相關(guān)部門培訓(xùn)工作，整理其他部門歸檔的培訓(xùn)文件。Supervise the training of other GMP related departments, organize and archive the training files of other department. 教育背景 Education Background 1. 具有化學(xué)、制藥及相關(guān)專業(yè)本科學(xué)歷；Bachelor degree in chemistry or pharmaceutical or related majors. 任職資格 Qualification 1. 有1 年以上相關(guān)工作經(jīng)驗。Have 1 year or above work experience. 2. 熟悉ICH Q7, GMP 等相關(guān)法規(guī)。Familiar with ICH Q7, GMP and relevant regulations. 3. 有很強(qiáng)的工作條理性、計劃性。Have a strong work ethic and planning. 4. 具有一定的語言基礎(chǔ)（中英文互譯）。Have a certain language foundation (Chinese-English translation). 5. 具有很強(qiáng)的團(tuán)隊協(xié)作意識和溝通技巧。Have strong sense of teamwork and communication skills. 6. 具有很強(qiáng)的任務(wù)執(zhí)行能力。Have strong ability of task execution.