1. Responsible for aseptic product production site management, on-time completion of
product production tasks, to ensure that the product meets the quality standards.
負責無菌產品生產現場管理，按時完成產品生產任務
，確保產品符合質量標準。
2. Responsible for equipment qualification, process validation and cleaning validation in
production department scope, including protocol drafting, qualification/validation
executing, and report summarizing.
負責生產部門範圍內的設備確認、產品工藝驗證和清潔驗證，包括方案編寫、確認/驗證執
行和報告總結。
3. Responsible for SOPs/BPRs drafting and revising in production department scope,
responsible for staff training.
負責編寫和修訂生產部門範圍內的SOP和BPR，負責員工培訓工作。
4. Responsible for proceeding and following up on deviations, changes and CAPAs
related to the production department.
負責處理和跟進與生產部門有關的偏差、變更和CAPA。
5. Responsible for safety management on production site, preventing accidents and
reporting safety risks and near miss events in a timely manner.
負責生產現場的安全管理，防止安全事故發生
，及時報告安全風險和安全隱患。
6. Complete other tasks as assigned by the superiors.
完成上級指派的其他任務。
任職要求：
1. Bachelor's degree with a major in pharmaceuticals and other related fields, 3 years’
experience in aseptic manufacturing. 2 years’ experience in people management.
本科學曆，主修製藥或其他相關專業
，3年以上無菌製劑生產工作經驗，2年以上的團隊
管理經驗。
2. Familiar with protocol preparing and implementing of sterile-related equipment
qualification, process validation and cleaning validation.
熟悉無菌製劑生產相關的設備確認、產品工藝驗證和清潔驗證的方案編寫和執行。
3. Experience with risk evaluation for aseptic manufacturing processes by common tools
and methods (RRF, FMEA, etc.).
能運用常用的風險評估工具和方法（RRF、FMEA 等）對無菌生產環節進行風險評估。
4. Proficiency in Microsoft office software, Familiar with manufacturing process of sterile
liquid injections, experience in GMP related documents drafting/revising/training.
熟練掌握微軟辦公軟件，熟悉無菌液體注射劑的生產流程，具有編寫/修訂/培訓GMP相關
文件的經驗。
5. Familiar with the processes and requirements for quality system elements such as
deviations, changes and CAPAs in the pharmaceutical industry. Experience in deviation
investigations and change control implementation.
熟悉製藥行業質量體係要素（如偏差、變更和CAPA）的流程和要求。具有偏差調查和變
更控製實施方麵的經驗。
6. High level of awareness of production safety and GMP aseptic behavior.
具備高度的安全生產和GMP無菌行為意識。
7. Good at English reading/writing skill, oral English is a plus.
良好的英語讀寫能力，具備英語口語能力更佳。