QA/qc Executive
1 week ago
**主要職責和責任**:
1. 參與內部GMP/GDPMD審核。
2.協助處理監控OOS、OOT、不合格、偏差和變更控制。
3. 訓練和監督一批實驗室分析/技術人員/檢查員,並依照既定程序監督測試/分析活動。
4. 履行合格人員的職責,並在部門主管的授權下審查、驗證和簽署測試/分析報告/批量生產文件以及放行/拒絕或用於生產和成品銷售的材料。
5. 透過SAP系統審核、驗證測試/分析報告和大量生產文件。
6. 更新規格、分析方案和QA/QC文件。
7. 監控穩定性方案/環境控制方案。
8. 協助製程驗證和改進製程/品質。
9. 推薦儀器、化學品和消耗品的採購。
10.負責儀器儀表的安裝、操作、校準、維護及修理。
11. 維護實驗室安全和內務管理計畫。
12. 準備和審查監管提交檔案的品質部分。
13. 進行標籤檢查並突顯與各自出口國和進口國規定的標籤要求的差異。
14. 主管建議/指導的任何其他項目/任務。
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