Key responsibilities include the following, but are not limited to: 1. Generate Quotations: - Coordinate CDA/agreements execution between Bora/Client - Coordinate internally to gather information required for quotation - Put together a quotation for Management approval - Provide quotations/project proposal to Client and follow-ups 2. Client Communication Management - Serves as a central hub of internal/external communications with existing clients/third parties for project and product changes - Serves as a central hub of internal/external communications with potential new clients /third parties to provide proposal to meet their 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 3. Project Planning: - Establishes project charter and plan to define project scope and timeline - Assign tasks and perform follow-ups to ensure timely deliverables - Identify potential issues and risks, and solutions. 4. 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 5. Perform other PMO-related duties/tasks as assigned by Management

To perform independently one or a limited number of specific functions within QA, the specific QA function could be: 1. Regulatory/registration documents review and preparation to meet local regulatory requirement or exported affiliate’s requirement. 2. Provide the assessment in site change control with regulatory point of view and coordinate with affiliates for site change control execution. 3. Coach and provide regulatory information and support. 4. Coordinate with affiliates for maintenances the most updated product licenses. 5. Be a site coordinator to handle the new/revised artworks approval process. 6. Package components management. 7. Document management 8. Change control management 9. Perform internal audits for assign topics. 10. Handle Site Quality Review Team Meeting 11. Others: Assign as requested by supervisor.

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。