外商資本額30億員工人數750人
1. To meet the productivity including the cycle time, wastage, outputs, yields, and quality objectives for all the production lines in the function section. And report the output daily and weekly basis.
滿足生產率,包括週期時間、浪費、產量、產量和功能部分所有生產線的質量目標。並每天和每周報告產量。
2. To ensure the team members are performing the production and GMP activities aligning with the procedure. And the SOPs are followed robustly.
確保團隊成員執行符合程序的生產和GMP活動。並嚴格遵守SOP。
3. Provide initial troubleshooting for program or equipment failures. And report the issues to the superiors.
提供程式或設備故障時的初步排除。並將問題報告給上級。
4. To perform daily Gemba on the production and site area.
每天在生產和現場區域執行Gemba。
5. To ensure the line clearance and line opening verification as per SOPs are robust.
確保按照SOP進行生產線間隙和開線驗證是穩健的。
6. To provide training to the team members about the operational and cleaning methodology of pieces of machinery/premises, material requisition, area clearance, process reconciliation procedures, in-process sampling checking and testing, environmental monitoring, cGMP, etc. in line with Standard Operating Procedures and Batch Records. Periodically provide training to the operators for the GMP awareness and the SOPs. And periodically verify the training effectiveness of the team members.
根據標準操作程式和批次記錄,為團隊成員提供有關機器/場所的操作和清潔方法、材料申請、區域清理、過程核對程式、過程中抽樣檢查和測試、環境監測、cGMP等的培訓。定期對操作人員進行GMP意識和SOP培訓。並定期驗證團隊成員的培訓效果。
7. Stop production and inform the superior of any abnormality or deviation that can impact the identity, quality, purity, and efficacy of the product. Maintain the cGMP and quality standards for the environment, equipment, and process within the responsible function section.
當有任何可能影響產品特性、品質、純度和功效的異常或偏差時停止生產並通知上級。在負責職能部門內維護環境、設備和流程的cGMP和質量標準。
8. To participate in the investigation of the deviation, customer complaint, Gemba, or inspection finding and be involved in the proposal and performing of the corrective/preventive action.
參與偏差、客戶投訴、Gemba或檢查結果的調查,並參與矯正/預防措施的提議和執行。。
9. To implement and practice good housekeeping and 5S in the respective section.
在負責的生產線中實施和練習良好的內務管理和5S。
10. Monitor and ensure shop floor staff adheres to all safety procedures.
確保現場工作人員遵守所有安全程序。
11. To conduct the assigned CAPA and CCR action to increase the quality and productivity of the production.
執行被指派的CAPA和CCR任務來提升生產品質與產能。
12. Perform any other duties as assigned to you by your superior.
履行上司分配給您的其他職責。
13. Responsible for daily on-site monitoring for most of the working time (≧80%), and responsible for personnel education, training and clerical related work for the remaining working time.
大部分工作時間負責每日現場的監控(≧80%),其餘工作時間負責人員教育訓練與文書相關工作。