面試經驗談

1. Review and provide the technical recommendations for CMC documentation and Common Technical Document(CTD) dossier from a regulatory perspective. 2. Interpretation and Handling the regulatory technical query’s responses that were asked by Client and Authority during the due diligence or submission deficiency phase and provide the action plan or solution and scientific justification. 3. Responsible for evaluating the registration feasibility and mapping the global registration strategy for assigned new R&D products. 4. Cooperate and teamwork with R&D, technical, and RA PM on new R&D project technical challenges and complete the dossier till product approval. 5. Responsible for regulatory registration for export products and make sure all the documents are meet the authority‘s requirements. 6. Responsible for deficiency response preparation to ensure our response meets the authority’s requirements. 7. Accurately follow the update of the registration regulation, and provide the regulation update to the team and training.

1. Support and facilitate business user‘s requirement to seamlessly running at corporate SAP system in the landscape via analyzing, designing, and developing. 2. Work closely with the team (other SAP developers, infrastructure & system teammates) to understand business needs and deliver features in good quality at timely manner. 3. Be capable of creating and assessing software architecture/designs with multiple stakeholders. 4. Manage overall change request and/or incident backlog for the owned topics and ensure the high quality of corrections and notes for the owned topic areas and of stable assist packages with no regressions. 5. Exhibit learning agility by quickly upskilling on new tasks and concepts. 6. Assist our business users during product deployment, critical operations, and system rollout via standard infrastructure, creating maintenance notes and documentation. 7. Will be providing presentations and workshops.

1. Plan and execute internal audits and special projects to evaluate the risks and the effectiveness of related controls. 2. Prepare reports for each engagement and communicate audit observations with corporate, regional, and local management. Apply problem solving skills to issues and provide practical and constructive recommendations. 3. Develop credibility and trust with operating functions to value-add internal controls and management. 4. Monitor changes in Company policies and procedures to align with the applicable Regulations, Standards, and industry practices.

1. Evaluation of submission feasibility for in-licensed products (major) and domestically manufactured products in the APAC region (KR, TW, HK, SG, MY, TH, VN, PH, and ID) 2. Coordination of the due diligence and production of the gap list 3. Evaluation and plan of the design, the budget, and the timeline for the bioequivalence study, the bridging study, and the clinical study in KR and TW 4. Communication with the APAC regulatory teams and partner companies to resolve the submission gap in the target markets 5. Design and consolidation of the regulatory strategy of the key milestone, the submission pathway, the submission timeline, and the launch timeline in the target markets 6. To review the License and Service Agreement 7. To support new submissions in Taiwan 8. To update of the APAC regulations 9. To prepare the consultation materials 10.To provide the justification materials on the non-clinical and clinical studies for the deficiency letter 11. To compile the ACTD format from the CTD format 12. To monitor submission progress on all company‘s projects 13. To provide improvement plans 14. The other tasks 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 4. 即時提供註冊用產品主檔案 5. 協助提供法規更新計畫 6. 即時支援產品維護用技術文件 7. 協助擬定合理且經濟可行之註冊計畫 8. 協助執行註冊計畫

1.協助幼兒學習自理生活。 2.提供幼兒日常生活的照顧。 3.維護幼兒在園所之安全。 4.教授幼兒課程。 5.配合幼兒發展狀況，設計、撰寫課程教案。 ※需為幼兒保育/幼兒教育相關科系畢業.

美語老師實務內容如下: 1.教授兒童美語課程. 2.教授輔助之美語教材. 3.配合相關教學活動. 4.課程介紹及教育訓練. 5.其他主管交辦事項. 應徵者需有兒童美語教學經驗.

兼職美語輔導老師 週一 . 三 . 四 . 五 下午3:00~8:00 工作內容: 1.指導美語課業、批改學生作業。 2.值班、監考。 3.美語補課教學。 4.美語電話測試。 5.美語電訪。 6.其他主管交辦事項。

大門接待、門禁管理、安全維護...等 月休8天

一個月基本授課時數55小時其餘時間協助行政事務 享勞健保、年終、績效....等

1.肉品配送：依公司安排，將冷凍/冷藏肉品安全送達客戶（餐廳、飯店、通路商等）。 2.貨物處理：協助倉庫人員疊貨、點貨，確保出貨正確無誤。 3.路線規劃：依配送清單及客戶地點，安排最有效率的送貨路線。 4.客戶服務：與客戶確認貨品數量、品質，維持良好合作關係。 5.款項處理：依公司規範，協助代收貨款並確實交回公司。 6.車輛管理：負責配送車輛的日常檢查與基本保養，確保行車安全。

１。開發潛在客戶，拓展市場，以達成業績目標。 ２。課程講師。 ３。國內業務接洽及訂單處理。 ４。產品展示並處理帳款相關事宜。 ５。線上業務推展，傳達及說明公司各項業務重大訊息、活動及產品。 　　薪資41600以上~ 　　對帶組織領管理訓練工作有興趣者

1.駕駛職業聯結車(半拖) 2.需具備職業聯結車駕照 3.需有經驗

*專業冷氣空調 VRV .多聯變頻.全熱交換.熱泵系統 ...安裝定位維修 *家用電器(電視.洗衣機.冰箱...) 安裝定位維修

1.負責部門相關文件之整理，建檔以及追蹤 2.完成業務主管其他交辦事項 3.協助業務完成報價等工作 4.顧客連絡資料整理 5.訂單之處理及整理

1.冷凍、空調設備施工、維修保養等各項工作事宜。 2.負責客戶之緊急維修服務。 3.處理相關廠商之協調及支援服務。 4學習冷凍、空調維修

1.冷凍、空調設備施工、維修保養等各項工作事宜。 2.負責客戶之緊急維修服務。 3.處理相關廠商之協調及支援服務。 4.需學習及理解能力佳，對冷凍、空調維修有豐富經驗者佳。 5.抗壓能力強、負責任。

1.廢水處理及設備操作，維修保養 2.廢水排放水質監控，符合污水排放標準 3.負責設備維修、巡檢、保養、整頓、異常排除、故障檢修等工作 4.具有相關證照，能獨立作業 5.主管交辦事務處理

1. 生產設備拆修作業與設備定期保養 2. 電路控制基本維修與機電故障異常查修排除 3. 主管交辦事務處理

✤ 管控庫存物料以及管理收貨、儲藏 ✤ 配合生產、發貨進度 ✤ 協助規劃跨部門間的物料流通並記錄庫存異動 ✤ 需要配合加班，以確保生產目標達成 ✤ 需有汽車駕照

1. 管理布料進出庫的記錄與檢查，確保數據準確。 2. 負責生產布料相關帳務處理，包含結算與報表製作。 3. 協助庫存盤點作業，維持庫存數據與實際一致。 4. 協調布料供應與需求，確保生產順暢進行。 5. 分析庫存與消耗數據，提供管理決策支援。 6. 確保帳務處理符合財務規範與政策要求。 7. 維護布料出入系統資料正確性，避免出錯。 8. 與相關部門溝通協作，提高布料使用效益。