工作內(nèi)容CONTENT
1. 審核執(zhí)行前批記錄及相關驗證文件。Review the template batch record.
2. 起草SOP。Draft SOP.
3. 起草項目及生產(chǎn)相關方案（例如風險評估、事件調(diào)查、中間體存放時間等）和報告。Draft the study protocol (e.g. risk assessment, incident investigation, intermediate storage time, etc.) and report for the process of project.
4. 起草生產(chǎn)計劃，協(xié)調(diào)外部門（分析、QA、研發(fā)）和部門內(nèi)部（庫房、設備）的工作安排，保證項目順利進行。Draft the manufacturing schedule. Coordinate the work arrangement of external department (QC, QA, PPD-FD) and internal department (warehouse, equipment) to ensure the smooth progress of the project.
5. 起草客戶投訴并制定跟蹤后續(xù)措施。Draw up customer complaints and follow up measures.
6. 負責生產(chǎn)過程中變更及偏差，并做其對應的評估、調(diào)查跟蹤及KAPA的實施。Responsible for changes and deviations in the production process, and conduct corresponding assessment, investigation and tracking and KAPA implementation.
7. 負責客戶審計及審計回復。Responsible for customer audit and audit response.
8. 解決生產(chǎn)過程突發(fā)事件并上報QA。Solve production process emergencies and report to QA.
9. 負責生產(chǎn)車間技術支持。Responsible for technical support of production
workshop.
10. 負責車間生產(chǎn)管理和人員安排。Responsible for workshop production management and personnel arrangement.
11. 負責生產(chǎn)設備報修。Responsible for repair of production equipment.
12. 組織安排操作人員的實操及SOP培訓工作。Organize and arrange practical operation and SOP training for operators.
13. 負責新建廠房過程中文件的起草審核。Drafting and reviewing documents in the process of building a new factory.
14. 完成其他相關工作。Execute other related tasks.
教育背景和任職資格EDUCATION BACKGROUND and QUALIFICATION
1. 藥物制劑、制藥工程或相關專業(yè)本科或以上學歷。Bachelor’s degree or above in pharmaceutical, electromechanical, mechanical or other related majors.
2. 五年以上生產(chǎn)質(zhì)量管理或相關工作經(jīng)驗。At least 5 years’ experience in production quality management or related work
3. 了解相關制藥法規(guī)，如《中華人民共和國藥品管理法》和GMP法規(guī)。Understand the relevant pharmaceutical laws and regulations, such as “The Drug Administration Law of the PRC” and “Good Manufacturing Practices”
4. 熟悉產(chǎn)品的工藝過程、SOP、質(zhì)量控制點，掌握關鍵設備的性能和操作。Familiar with the product process, SOP, quality control point, master the performance and operation of key equipment.
5. 具有工藝問題分析能力、設計方案能力、判斷能力、操作能力、與他人溝通能力。Have ability to analyze process problems, design protocols, judge, operate and communicate with others.
6. 具有生產(chǎn)管理的能力。Have the ability to manage the production.
7. 具有獨立解決產(chǎn)品工藝問題的能力。Have ability to solve process problems
independently.
8. 熟悉電腦文檔操作。Familiar with computer documentation operation.