製程專員 Manufacturing Process Specialist (製程技術員)
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月薪
37000元以上
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無工作經驗可
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大學
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求才人數：1人
Responsible for the packaging site cGMP, record, and operation compliance, and elimination of potential risks. 負責包裝現場的cGMP、紀錄、操作的合規性，以及消除潛在風險。
Periodically review and revise the GMP documents(e.g., SOP, etc.) to ensure documentation compliance. 週期性審核GMP文件(如: SOP)以確保文件與流程吻合。
Involved in the cross-function optimization project to increase the process from the quality perspective. 參與跨部門優化專案以期從品質角度提升流程。
1. Responsible for the GMP operation effectiveness on the packaging production sites.
負責包裝現場的GMP操作有效性。
2. Responsible for the site work in progress and AQL sampling following appropriate specifications.
負責現場的製程間管控(IPC)以及AQL取樣符合規範。
3. To perform the line clearance confirmation to eliminate the mix-up risks.
執行清線確認以消除混批風險。
4. To perform periodic reviews of the GMP document for the packaging, provide and proceed to the optimization proposal about the detected gaps.
執行週期性包裝部門相關GMP文件審核，針對偵測到的流程不足提案/執行優化建議。
5. To govern and enforce the cGMP processes, 5S, implemented CAPA, and quality procedures are in place and follow