美時化學製藥股份有限公司
生產專員 Manufacturing Specialist
9/30 Cập nhật
Array
Tiếng Anh Điều kiện
Toàn thời gian
Mới tốt nghiệp
Tiếng Anh Điều kiệnLương & địa điểm làm việc
Lương hàng thángNT$ 28,000+
南投縣南投市
Điều kiện
Yêu cầu ngôn ngữ
Tiếng Anh
聽/中等、說/中等、讀/中等、寫/中等
Kinh nghiệm
不拘
Mô tả công việc
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 followed strictly.
監管並確保符合cGMP的流程、5S、CAPA導入、以及有品質管控的流程在線且被嚴格遵守。
6. Monitoring the OEE system and data. Periodically propose the optimization plan.
監管OEE的系統與數據。週期性提出優化建議。
7. To perform packaging-related deviation/customer complaint investigation. And carry out the related CAPA. 參與/執行包裝部門相關的偏差/客訴調查，並執行相關CAPA。
8. To provide the training of the GMP awareness to the production team.
給予製造/包裝部門提供GMP議事相關的教育訓練。
9. Carrying out the periodic Gemba walk. 執行週期性巡線。
10. To assist with the quality audit and related tasks. 支援品質稽核以及相關任務。
11. Involvement in the production operation optimization project. 參與製程優化專案。
12. Responsible for the data integrity record of the packaging team.
負責包裝部門符合數據完整性的紀錄。
13. Collaborate with departments to ensure the quality issues and documents are escalated and solved timely manner. 跨部門合作以確保品質相關文件及議題及時被呈報且解決。
14. To perform the task assigned by the supervisor. 執行主管交辦事項。
Số lượng tuyển dụng
1~1人
Trình độ học vấn
大學(學院)以上
Yêu cầu ngành học
自然科學學科類、醫藥衛生學科類、工程學科類
Giờ làm việc
8:00-17:00
Chế độ nghỉ
週休二日
Loại công việc
Administrative Assistant
Production Controller Assistant
ISO / Quality Assurance Staff
南投縣南投市
藥品製造業
美時化學製藥成立於 1966 年，是一個立足台灣、放眼國際的學名藥廠，目前為台灣營收規模最大的製藥公司，專注生產口服癌症用藥並銷售全世界。
美時以亞洲地區最頂尖的研發中心與生產設備，也是台灣唯一同時獲得美國 FDA、歐盟 EMA、日本 PMDA、中國 FDA 及巴西 ANVISA 認證的藥廠，全力以高品質、高近用性的藥物滿足未竟的醫藥需求，改善人類生活品質，致力為病患、員工與所有利害關係人創造最大利益。
透過目前足跡廣布台灣、韓國、泰國、越南、新加坡、香港、馬來西亞、菲律賓、與中國的直營市場，以及與一線藥廠成為合作夥伴，美時的高價值產品得以銷售至世界各角落，是少數能進軍所有國際市場的台灣藥廠。
