1. 執行製程管制試驗、IPC取樣、製程檢驗。 2. 各製程階段半成品、成品及安定性取樣。 3. 協助執行現場環境監控與設備清潔確效抽樣。 4. 協助GMP異常的調查、文件整理、歸檔及主管交辦事務處理。 ※輪班津貼另計，三班作業，現以早班/中班為主。

 Review Quotations: - Ensure CDA/agreements execution between Bora / TWi BD and Client - Coordinate internally with BD to gather information required for quotation - Review quotations and proposal prepared by BD for Management approval  Client Communication Management - Serves as a central hub of interna/external communications with existing clients/third parties for project and product changes - Provide proposal to meet customer and internal needs and to enhance company business opportunities - Confirm efficient and accurate information exchange between parties - Schedule and arrange project meetings and task assignments, communicate expectations and changes to project team members, record meeting minutes/critical decisions and track completion of project deliverables to ensure quality and integrity of all project-related products  Project Planning: - Create project plans to define project scope and timeline - Assign tasks and perform follow-ups to ensure timely deliverables - Identify potential issues and risks, and solutions.  Project Execution and Delivery: - Drive project activity execution to meet goals/objectives and the agreed plan without compromising project deliverables or relationships - Propose solutions on a variety of issues with low to moderate complexity and changes - Gather information, and apply analytical and interpretation skills to tackle problems of diverse scopes - Help resolve project conflicts, identify resource requirements and align project teams on common project scopes and objectives - Track and maintain regular and ad hoc reports to gauge progress and performance status - Complete work in accordance with PMO’s best practices and methodologies - Assist in managing multi-cross functional team works to meet successful deliverables/outcomes - Ensure compliance with up-to-date regulatory guidance. - Leverage robust project management skills and co-work with project managers to drive key decisions and milestones according to the endorsed plans, timelines, costs, and quality parameters  Perform other PMO-related duties/tasks as assigned by Management

1. CDMO專案： (1) 參與CDMO客戶會議討論，並配合討論內容修改製程設計。 (2) CDMO專案技術轉移相關文件(protocol, report, and master batch records)之制定、教育訓練及執行。 (3) CDMO專案之預試驗、試製及GMP生產批 (Lab-scale & Submission/Commercial batch scale)，並執行廠內教育訓練。 (4) 料號管理、原物料請購及庫存管理。 (5) 專案進度追蹤及其他因異動而進行之即時性調整。 2. 製程相關驗證確效作業： (1) 製程設備之性能驗證計畫書及報告書之制訂及審閱、協調相關部門依計畫書內容執行及分析結果，並於執行前安排教育訓練。 (2) 確效主計畫書之維護及更新。 (3) 製程確效、清潔確效、無菌製程模擬確效 (Aseptic process simulation; media fill)及其他。 (4) 驗證確效排程及進度管理。 3. 市售產品trouble shooting： (1) 市售產品發生異常事件時，協助品質部門執行相關技術性之調查。 (2) 市售產品安定性數據發生異常時，經調查後依規定進行處方或製程優化。 4. 部門行政事務： (1) 請購清冊及固資清冊管理。 (2) 主管交辦事項。