Laboratory Supervisor 實驗室主任

1. Laboratory Performance:
1-1. Design, develop, research and validate new analytical methods/experiments to support product development and process improvements.
1-2. Lead complex chemical and data analyses on raw materials, in-process samples, and finished products using advanced instrumentation (GC-FID, GC-MS, HPLC, etc.)
1-3. Oversee the calibration, maintenance, and troubleshooting of sophisticated laboratory equipment to minimize downtime.
1-4. Lead investigations into Out-of Specification (OOS) or Out-of-Trend (OOT) results, implementing corrective and preventive actions (CAPA) for root cause analysis.
1-5. Partner with the Production Department and other Group’s experts to troubleshoot manufacturing issues and facilitate smooth technology transfers from lab to plant scale.
1-6.Provide technical guidance and training to junior chemists and lab technicians.

1-1.設計,研究並驗證新的分析方法和實驗,以支持產品開發和工藝改進。
1-2.對原料、樣品和成品進行化學分析和數據判斷,使用儀器如GC-FID, GC-MS, HPLC 等。
1-3.監督實驗室精密設備的校準、維護和故障排除, 以減少停機時間。
1-4.主導對超出規格OOS或異常曲線OOT結果的的調查,實施矯正預防措施CAPA 進行原因分析。
1-5. 與生產部門及集團其他單位配合,解決制造端的問題,提升從實驗室到工廠端的技術順利轉移。
1-6. 為實驗室同仁提供技術指導和培訓。

2. Compliance & Quality
2-1 Ensure all laboratory activities comply with ISO and cGMP-like standards.
2-2 Author and review Standard Operating Procedures (SOPs) and technical reports.
2-3 Author and review Standard Operating Procedures (SOPs) and technical reports.
2-4 Performs laboratory analysis according to related working instructions.

2-1 確保所有實驗室程序符合ISO和cGMP 標準 。
2-2 編寫和審核SOP標準操作程序及技術報告。
2-2 根據相關操作說明進行實驗室分析。

3. QHSE(E)
In his/her field:
Be the guarantor of employee safety, as senior, and ensure compliance and enforcement of the Group's safety approach, application of safety instructions, procedures and work instructions in force.
To control the proper application of health, safety, quality and environmental procedures and rules and to propose improvements.

確保集團安全方針的遵守與執行,落實現行的安全要求、程序和作業指導書。
監督健康、安全、質量和環境相關程序及規定的正確執行,並提出改進建議。