職務內容

1.Oversee the Laboratory Out of Specification (OOS) and Out of Trend (OOT) test results investigations and ensure root cause analysis and documentation.
監督實驗室超出規範 (OOS) 和超出趨勢 (OOT) 測試結果調查，並確保根本原因分析和記錄。
2.Serve as the technical expert and assist laboratory staff with troubleshooting as well as working actively with Managers and Supervisors for all disciplines in resolving corrective actions and timely completion of reports.
擔任技術指導以協助實驗室工作人員進行問題排除，並與所有經理和主任積極合作，解決問題、提出矯正措施並及時完成報告。
3.Participate in process improvements and will assist with the development of laboratory procedures in accordance with current testing guidelines and current GMPs.
根據現有的檢驗方法和GMP程序去參與相關流程的改進。
4.Ensure compliance with stability studies programs.
確保穩定性研究計劃的合規性。
5.Monitor laboratory metric trends on a regular basis and ensure that appropriate investigation, corrective actions and/or escalation are conducted as required for recurring trends involving products, methodologies, instrumentation, and scientists.
定期監控實驗室指標趨勢，並根據其趨勢確保涉及到產品、分析檢驗方法、儀器和實驗室人員的作業流程並適當的進行調查、糾正措施和/或升級。
6.Provide regulatory inspection audit support (front room, back room, and SME).
對於常規性檢查稽核提供支援。
7.Lead/sponsor the implementation of improvement initiatives to address recurring laboratory issues.
主導/協助實施改進計劃，以解決反覆出現的實驗室問題。
8.Monitor the progress and process for troubleshooting and investigation studies for laboratory issues to ensure appropriate and consistent use of investigative tools and problem-solving techniques.
控管實驗室的問題排除和調查研究的過程，以確保是使用一致的調查方式和問題解決的方法。
9.Review and approval of Quality Records (e.g. non-conformances, CAPA) related to laboratory events.
審查和批准與實驗室相關的品質記錄（例如不合規紀錄、CAPA）。
10.Assess new technology and laboratory automation to increase laboratory efficiency, reduce testing time, reduce data variability, minimize chemical consumption, and reduce waste.
評估新檢驗技術和實驗室的自動化，以提高實驗室效率、縮短測試時間、減少數據可變性且最大限度地減少化學品消耗、減少浪費。
11.Maintain up-to-date knowledge of the company’s products and manufacturing processes as well as industry and regulatory trend related to relevant laboratory testing.
保持對公司產品、製造流程、與相關實驗室測試相關以及稽核趨勢的最新了解。
12.Plan, promote, and organize required training activities related to different laboratory testing areas.
計劃、促進和組織與不同實驗室測試領域相關的必要訓練活動。
13.Communication and elevate critical business-related issues as well as opportunities to senior management.
與高階管理層溝通和提升與業務相關的關鍵問題。

需求條件