竹北分公司-品質管控處/品管生化部-研究員

1.協助執行生物活性相關分析方法之確校、資格確認及方法生命週期管理，如計畫書撰寫與方法績效監控。
2.協助執行內部研發團隊及外部客戶之分析方法技術轉移，建立符合法規且可受稽核之檢測能力。
3.依GMP要求，使用SHR、ELISA、qPCR、細胞分析等平台執行製程中樣品、原液及成品之生物活性與生物分析檢測。
4.執行偏差調查、根本原因分析、CAPA改善措施及數據趨勢分析，以確保產品品質符合法規需求。
5.負責實驗室儀器、電腦化系統及設備生命週期管理。

1.Assist in excution analytical method validation, qualification, and lifecycle management for bioactivity-related methods, including protocol/report preparation and performance monitoring.
2.Assist in excution analytical method transfer activities from both internal excution
Assist i"development teams and external clients, and collaborate with cross-functional teams (QC, Analytical Development, Process Development, QA, PM to establish robusty -fompliant, and inspection-ready testing capabilties.
3.Support bioactivity and biological analytical testing for in-process, drug substance, and drug product samples using platforms such as SPR, ELISA, qPCR, and cell-based assays in compliance with GMP requirements.
4.Conduct investigations for deviations, OOS/OOT results, root cause analysis, CAPA implementation, and data trending to ensure product quality and regulatory compliance.
5.Oversee laboratory instruments, computerized systems, and equipment lifecycle activities, including maintenance, qualification, and compliance oversight.