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工作內容 Job Description 1. 學習《藥品生產質量管理規范》對機構與人員、文件管理的要求，以協助部門負責人負責文件和培訓工作；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. 負責與相關部門團隊協調溝通，將工作任務進行合理分配；Responsible for communicating with relevant department and team, assign work reasonably. 4. 負責GMP 文件統一編號的管理；Responsible for the management of GMP document numbering. 5. 負責紹興廠區的SOP 管理；Responsible for SOP management of Shaoxing Site. 6. 負責本部門文件、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. 負責編制文件和檔案的管理目錄；Responsible for preparing the list of document and file. 8. 負責文件接收、發放、登記、分類、歸檔等的管理；Responsible for receiving, distributing, registering, classifying, archiving of document. 9. 負責客戶文件的登記、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導；Report to superior if the received document can not meet the requirement. 11. 負責新員工GMP 意識培訓，本部門培訓工作及紹興公司各部門培訓文件管理；Responsible for GMP awareness training for new employees, managing the training of QA department and the training documents of each department. 12. 負責編制本部門年度培訓計劃，整理培訓記錄，定期考核培訓效果、完成培訓總結；Responsible for the preparation of the annual training plan, organizing training records, assessment of the training effectiveness and completing training summary. 13. 負責編制GMP 和質量相關的培訓資料，協助部門負責人對公司全員開展 GMP 培訓；Responsible for the preparation of GMP and quality-related training materials, and assist to carry out GMP training for staff. 14. 負責編制GMP 和質量相關的考核試卷，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 相關部門培訓工作，整理其他部門歸檔的培訓文件。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、制藥及相關專業本科學歷；Bachelor degree in chemistry or pharmaceutical or related majors. 任職資格 Qualification 1. 有1 年以上相關工作經驗。Have 1 year or above work experience. 2. 熟悉ICH Q7, GMP 等相關法規。Familiar with ICH Q7, GMP and relevant regulations. 3. 有很強的工作條理性、計劃性。Have a strong work ethic and planning. 4. 具有一定的語言基礎（中英文互譯）。Have a certain language foundation (Chinese-English translation). 5. 具有很強的團隊協作意識和溝通技巧。Have strong sense of teamwork and communication skills. 6. 具有很強的任務執行能力。Have strong ability of task execution.