1.開發調整分析方法(HPLC, GC, IC…),協助產品製程開發,分析方法之確校;2.執行實驗室設備3Q;3.研擬審查藥典相關產品規格及分析測試,建立藥典規格;4.操作化學分析儀器進行分析,協助產品放行…
學名藥開發
1.Facilitate Lot disposition process, reviewing GMP docs and managing timelines;2. Support day-to-day Quality Assurance – Operations;3.Perform batch disposition activities within specified timelines…
待遇面議
1. 協調法規相關部門與供應商評價授權產品
2. 評估產品於亞太地區註冊之可行性,準備註冊所需相關技術文件與試驗
3. 在產品開發及送件準備期間提供法規要求的指引,協助其符合國際法規…
待遇面議
1. Review and provide the technical recommendations for CMC documentation and Common Technical Document(CTD) dossier from a regulatory…
待遇面議
This position is located at Lotus Taipei office and work closely with global RA team mainly take care in-licensing projects. The ideal candidate has strong RA experience with Asia or South East Asia region new submission and life-cycle production management…
待遇面議
1. Review and provide the technical recommendations for CMC documentation and Common Technical Document(CTD) dossier from a regulatory…