美時化學製藥股份有限公司

※※※擴大徵才，工廠提升計畫完工，製藥產線擴大生產規模※※※ 依廠內標準作業程序和現行GMP規範，按排程和製造批次執行產品製造，工作內容包含： 1. 負責執行產品生產相關工作 2. 負責執行產品之製造 3. 負責生產進度及狀況，確實填寫批次記錄及相關表單 4. 執行設備及工作環境清潔及維護 5. 包裝機台操作(片裝、瓶裝、盒裝、裝箱等)及相關紀錄填寫 6. 其他主管交辦事項 加入我們的美時製藥產線團隊，讓您的技術熱情得到最大發揮！ 您將獲得製藥工藝和高品質生產技術的完善訓練及升遷制度，立即加入我們，美時是您製藥成就發展之路的唯一選擇！

1. Develop analytical methods, perform analytical tests, and assist the RD team in screening formulations for the NDA and ANDA drug development. 制定分析方法，進行分析測試，並協助RD團隊篩選用於NDA和ANDA藥物開發的製劑。 2. Follow laboratory SOPs and ensure GMP compliance. 遵循實驗室SOPs並確保符合GMP規範 3. Prepare technical documents and review data for the R&D projects and drug submission. 為研發專案和藥物開發準備技術文件並審查數據 4. Responsible for performing the R&D tasks and projects, such as analytical method development, method validation, formulation screening, raw material tests, finished product release, stability study, and dissolution testing.負責執行研發任務及專案，例如分析方法開發、方法確效、配方篩選，原料測試、成品放行、安定性研究和溶出度測試。 5. Use and maintain analytical instruments, GC, HPLC, UPLC, Dissolution Tester, Titrator, Particle size analyzer, etc. Research, diagnose, troubleshoot, and identify solutions to resolve analytical instrument issues. 使用和維護分析儀器，GC，HPLC，UPLC，溶出度測試儀，滴定儀，粒徑分析儀等。研究，診斷，故障排除和識別解決方案以解決分析儀器問題。 6. Train, lead, and supervise junior analysts in day-to-day laboratory operations. Support relevant departments and vendors to complete projects on time, ensure the work and analysis comply with GMP and SOPs. 訓練、領導並監督日常實驗室操作中的初級分析師。協助相關部門和供應商按時完成專案，確保工作和分析符合GMP和SOPs。 7. Review documents, prepare the analytical study report and CMC documents 審查文件，準備分析研究報和CMC文件 8. Responsible for establishing, maintaining, and updating the specifications and test methods for in-process and finished products in the pre-approval phase. 負責核准前半成品和成品試驗相關之檢驗方法與規格之制定、維護與更新。 9. Support assigned responsibilities to maintain GMP compliance of the chemical laboratory, as applicable. 依據分配責任，維持化學實驗室運作皆符合GMP規範 10. Promptly complete work and tasks assigned by superior 及時完成上級下達的工作和任務。 11. Support for analytical method transfer to analytical control, QP sites, and other receiving laboratories. 協助將分析方法轉移到分析控制，QP所在地和其他接收實驗室。 12. Cooperating with PD & RA, complete and all lab tests. 配合PD及RA完成各項化驗項目。 13. Ensure analysis can be conducted with efficiency and completed on time 確保分析工作得以高效率及迅速之進行。 14. Managing and maintaining instrument calibrations, laboratory instrument logbooks, and SOPs. 各儀器設備SOP之制訂、管理、定期維護、校正如期完成。 15. Ensure lab work is conducted according to SOP and complies with EU, US, JP, and global cGMP regulations. 確保其實驗操作皆依照SOP進行，並符合歐美日地區及全球cGMP之規定。

1. 具備問題分析能力，可有效地與使用者溝通，解決用戶端電腦周邊硬體系統問題。 2. 熟悉網際網路TCP/IP通訊協定，基本網路設備(Hub, Switch, Firewall)管理及維運。 3. 熟悉系統硬體如:伺服器主機硬體，磁碟陣列，SAN交換機安裝，規劃，管理與維運。 4. 熟悉Server作業系統(Windows 與 Linux) 安裝，規劃，管理與維護 5. 建立VM系統相關營運管理制度及備援處理程序，管理VM系統自動化及流程改善，維護相關管理文件。 6. 實體機房管理與維護，包括UPS不斷電系統，機房監控系統。 7. 管理系統維護廠商及合約簽訂事宜，規劃與執行系統年度專案與預算，與專案內外部相關工作之溝通協調。 8. 網路流量及系統效能監控、系統硬體狀態日常巡檢，建立服務告警分析、障礙排除。 9. 配合資安設備政策規劃及調整相關設定，辦理例行性系統災難復原演練事宜。 10. 其他主管交辦事項。

1. Utilizing strategic sourcing process to identify, negotiate and implement packaging materials, indirect materials, procurement initiatives to drive cost savings. 2. Align with sourcing team to provide local business requirements and market information to support effective collaborative regional strategy creation and execution 3. Partnering with RD / RA/ NPL, and other Functional groups (Executives, Quality, R&D, Regulatory Affairs, Finance, Legal, Engineering….) in discovery, contract negotiation, optimizing economic value, on-time delivery of product & services, cost management & reduction, supplier & partner risk mitigation, and scope of work development. 4. Develop and implement forward thinking procurement strategies to both optimize spending and minimize risk. 5. Creation of effective preferred supplier program and instillation of organizational discipline on onboarding new vendors. 6. Development of KPIs for strategic sourcing with cyclical delivery which drives continuous improvement.

1.To enact, modify and perfect current EHS system in order to meet the government requirements.健全及優化環安衛管理法令循度。 2.Regularly and monthly EHS checkup in order to find the latent EHS and safety problems, propose appropriate measures and assist and monitor other departments problems solving.環安衛定期稽核、持續改善及追踨管理。 3.Regularly provide training for employee and contractors or visitors regarding EHS, safety and security.執行環安衛教育訓練。 4.Arrange regularly solid waste and hazardous waste disposal 安排廢棄物定期清運 5.Develop, conduct and maintain employee health examination program 建立執行及維護員工健康管理 6.Develop and implement chemical/Activate Pharmaceutical Ingredient(API) safety management program;design and implement occupational exposure monitoring. 建立及執行化學品/活性藥物原料安全管理程序；規劃及執行職業暴露監測 7.Design and perform the Jar-Test for determining a appropriate waste water treatment method or parameter for the new chemical or raw material. 規劃或執行瓶杯試驗，以針對新的化學品或物料決定其最適當之廢水處理方式或參數

1.於官方和客戶查廠時協助相關稽核工作執行，以確保品質系統符合cGMP之要求。 2.安排產品年度評估的時程，並追蹤完成。 3.協助變更管制文件的流程管理，追蹤變更管制文件如期完成。 4.管理廠內的調查系統，並確保客訴調查、偏差調查與超出規格事件調查於時間內完成。 5.確保CAPA系統之有效性，並追蹤CAPA於時間內完成。撰寫CAPA年度報告。 6.協助和審閱風險評估報告。 7.協助廠內人員教育訓練計畫並管理Compliance Wire、 Blue Mountain系統。 9.協助與執行廠內改善和提升法規符合的品質改善計畫 10.管理電子化系統文件流程，協助文件發放、收回與歸檔。 11.ERP系統的主檔管理與審核 12.依合理要求管理其他品質相關活動

1.Perform QA on the floor GxP activities. 2.Ensure manufacturing / operations compliance with applicable procedures and batch / GxP records. 3.Ensure the personnel in the operations are having sustainable GMP mindset. 4.Perform real time review of manufacturing batch records. 5.Review manufacturing shop floor documentation.

1.協助主管規劃廠房、設備、生產、Artwork、品質制度等運作落實，以提昇部門績效。 2.協助各類專案之規劃與執行。 3.完善人才培訓體系及晉升發展管道。 4.100％藥廠CGMP訓練。

1.負責藥廠生產設備的緊急維修及保養針對打錠機、膜衣機、膠囊充填機、烘箱、流動層造粒機、粉碎機及包裝設備。 2.具有藥廠文件處理經驗，並能支援確效作業、維修、協助偏差文件處理、部門內SOP的建立或修改及負責CAPA的有效性確認。

- Evaluation of submission feasibility for in-licensed products (major) and domestically manufactured products in the APAC region (South Korea, Taiwan, Hongkong, Thailand, Singapore, Malaysia, Vietnam, Philippines, and Indonesia) - Conduction of the dossier audit and production of the gap list - Evaluation and plan of the design, the budget, and the timeline for the bioequivalence study, the bridging study, and the clinical study in South Korea and Taiwan - Communication with the APAC regulatory team and partner company to resolve the submission gap in the target market - Design and consolidation of the regulatory strategy of the key milestone, the submission pathway, the submission timeline, and the launch timeline in the target market - Support of new submissions in Taiwan - Dossier Compliance from CTD format to ASEAN format - Update of the APAC regulations - The other tasks