GMP實驗室助理 GMP Lab Assistant (歡迎應屆畢業生加入)

1. Responsible for distributing, overseeing and carry out raw material/package material, semi-product/product and stability analysis, sampling and records, issue blank report to ensure product quality meets PIC/S GMP requirements.
負責分配、督導以及執行原物料、半成品/成品及各產品相關安定性之檢驗分析、抽樣紀錄、開立化驗報告，以確保產品品質符合 PIC/S GMP 要求。

2. Review of group members’ project plans and analysis result reports, inspection/test reports, and SOPs.
審核所屬組員各計劃書與分析結果報告、檢查/檢驗報告、標準操作程序(SOP)。

3. Carry out all cleaning and maintenance operations, calibration/verification and report sorting to maintain normal operations of instruments and equipment.
執行各項儀器設備清潔保養、校正/驗證及報告整理，以維持儀器設備之正常使用。

4. Draw up and maintain a SOP for instruments and equipment. Maintain the integrity of usage records, and be responsible for calibration and validation annual assessments (if necessary).
制訂及維護儀器設備 SOP、維護使用紀錄之完整性並負責校驗證年度評估(如果需要)。

5. Dispose of laboratory organic waste safely and clean the area to maintain laboratory environment security (including assisting with managing and declaring toxic chemical compounds and controlled drugs).
執行實驗有機廢棄物之安全清除、環境衛生打掃，以維持實驗室環境安全衛生。(包含協助毒化物及管制藥品之管理與申報)

6. Management of chemical reagent and Reference/Working standard.
管理化學試藥和參考/工作標準品。

7. Supervise the facilities and instrument of stability room/chamber are well functioning and retention room/shelves are well controlled and well-ordered.
管理安定性實驗室之設施及儀器設備功能正常，留樣室及儲架空間保持井然有序。

8. Perform self-inspections or internal audits as required by the audit schedule.
按照審計計劃的要求進行自我檢查或內部審計。