品管實驗室人員

1. 執行物料、原料、半成品、成品…等分析檢驗。 2. 藥品分析方法確效計畫書/報告書撰寫與分析執行。 3. 分析儀器操作管理(如GC, HPLC, UV, IR…等)。 4. 實驗室儀器設備驗證、校正、保養、維護與改善，確保設備有效運轉。 5. 依據法規制定及修訂部門內計畫書、標準作業指導書及相關紀錄等文件。 6. 遵守實驗室規範，完成主管交辦事項。 7. 具備法規/文獻收集與閱讀能力。 1. Follow laboratory SOPs and ensure GMP compliance. 2. Responsible for performing the QC tasks and projects, such as analytical method development, method validation, raw material and finished product tests. 3. Use and maintain analytical instruments, GC, HPLC, UV, IR, etc. Research, diagnose, troubleshoot, and identify solutions to resolve analytical instrument issues. 4. Establishing, maintaining, and updating the specifications and test methods. 5. Support assigned responsibilities to maintain GMP compliance of laboratory. 6. Promptly complete work and tasks assigned by superior. 7. Managing and maintaining instrument calibrations, laboratory instrument logbooks, and SOPs.