4/30 日本食品零食標籤翻譯文件排版人員
- 富山國際貿易股份有限公司
- 綜合商品批發代理業
- 桃園市龜山區
- 經歷不拘
- 學歷不拘
工作內容: 1. 日本商品背標翻譯校對修正。 2. 報關報驗資料傳遞。 3. 台灣FDA食品衛生法規相關條例查詢。
工作內容: 1. 日本商品背標翻譯校對修正。 2. 報關報驗資料傳遞。 3. 台灣FDA食品衛生法規相關條例查詢。
製造單位專業文件英語翻譯(如:指導書、說明書) 時間彈性,上班時段可視個人情況調整 非遠端工作。
1.負責國產及輸入查驗登記事宜,含藥品、醫療器材、化妝品、食品。 2.各項許可證變更登記及展延之辦理。 3.主管交辦事項。
Responsibilities: Project Coordination: • Support PD/PM with client reports and meeting preparations • Assist in permit applications and communication with clients/government authorities • Facilitate technical/administrative discussions with clients, with support from various company disciplines • Aid in documentation for payment collection and track procurement/logistics for critical materials • Coordinate client approval for Mandatory Spare Part and Special tool list, liaising with internal service team for timely delivery • Support translation of client correspondence or technical documents Client Training Coordination: • Support the completion of remaining training sessions for the project • Coordinate with Client, Company Project, Engineering, and Training Center for the Client Training Program • Facilitate each training session, acting as the focal point for the customer to ensure smooth completion • Collaborate with training instructor for English-Mandarin interpretation • Translate complex problems and concepts in training for participant understanding • Manage and maintain in-house training facilities and equipment Requirements: • Strong leadership and self-starter • Good communication skills in English and Mandarin (additional languages are a plus) • Excellent interpersonal skills for presentations, meetings, and discussions • Part of Project Execution Team • Reports directly to Project Director/Project Manager 【其他補充】 1.電廠機械設備客戶端 教育訓練教材 英文-中文 翻譯工作(比重不高) 2.主管為台灣人,但企業內部溝通文件資訊均以英文為主 3.如果有工程背景或是有在電力設備/EPC 統包工程領域經驗加分,但非必須 4.英文聽/說/讀/寫 需精通 5.此為外商合約制職位,合約一年一簽,後續依照企業需求或是工作表現提供 續約/轉正/調薪 等規劃
1.主管會議、工安會議即時日語口譯。 2.依據需求,進行資料或文件翻譯。 3.協助現場日本工程師口譯與溝通協調。 4.協助處理公司交辦的行政總務事項。 5.需要進無塵室現場幫忙翻譯工作 6.需要能配合平日加班和周六偶而加班 7.上班時間早上八點到下午五點 8.駐廠桃園龍潭友達廠上班,6月到12月初大約半年時間
1.編寫產品說明書與技術手冊相關文件。 2.製作國內、外申請公部門產品登記相關文件。 3.辦理產品包裝標示合規化申請相關作業。 4.文件管理中心作業。 5.蒐集與彙整文獻資訊。 6.主管交辦事宜。
1. 建立並維護生產單位之一般性文件、技術文件以及GMP相關文件。 2. 製程移轉、試劑、製程放大以及製程改善相關文件與事務處理。 3. 變更管制、異常與客訴之相關事務處理。
1.相關工程、設備資料彙整、撰寫及編譯(需中英文撰寫) 2.建立並維護生產單位之一般性文件、技術文件以及GMP相關文件(需中英文撰寫) 3.若有外部客戶、查廠時需使用英文協助溝通
1 執行製劑廠生產相關文件撰寫 1.1 設備驗證相關4Q文件 1.2 設備清洗記錄、BPR修訂 1.3 Media Fill之BPR、Media Fill計劃書/報告書 1.4 產品製程確效及清潔確效計畫書/報告書 1.5 製程技術相關資料如流程圖等整理 2 執行生產相關標準作業程序撰寫 2.1 生產標準作業程序撰寫 3 變更管制相關事務處理
1.原料藥(drug substance)、製劑(drug product)等產品的註冊文件編寫、改版/變更管制及年度維護等。 2.具自我時間管理能力,準時完成負責文件的製作及指派的工作任務。 3.主管交辦事務
We are looking for a Technical Account Manager who will be responsible for building and maintaining post sales relationships with QCT’s largest and most complex partner. You will serve as a trusted advisor, ensuring successful QCT's solution deployment and adoption. Key responsibilities: • Provide advice and guidance as the subject matter expert to ensure successful services • Deliver training to user groups to support organizational adoption • Function as a frontline technical resource for “best practice” and informal partner questions • Engaging with support services as a customer advocate to ensure speedy resolution of customer issues • Engaging with Product management as the customer advocate on product roadmap discussions • Maintain current functional and technical knowledge of support services • Last but not the least, deliver and exceed on all performance targets.
1.製作撰寫各車型車主手冊、車輛操作手冊。 2.製作撰寫各車型維修技術手冊、電迴路手冊,以提供技術部門使用。 3.製作撰寫緊急應變手冊。 4.製作撰寫零件手冊。 5.協助海外車型文件校稿。
1.進行例行性售後服務(如:客戶拜訪、產品狀況了解及客訴處理)。 2.建立售後服務制度。 3.回覆客戶應用技術的問題,提供產品技術諮詢。 4.提供客戶技術服務,必要時外勤至客戶處安裝、檢修儀器設備。
1. 一般文書資料處理及歸檔。 2. 熟悉Microsoft Office操作。 3. 撰寫文件與製作簡報。 4. 各類文件校稿。 5. 協助處理主管交辦之行政文件事項。
1. 翻譯公司內部技術文件。 2. 依據客戶需求,進行資料或文件翻譯。 3. 進行影音產品如音樂或影片等翻譯工作。 4. 進行工作現場即時口譯。 5. 協助國外主管現場口譯與溝通協調。
1. Department Translator 2. Occasionally accompany supervisor to site for interpretation 3. Related office affairs / 1. 翻譯專員(中英或中韓) 2. 偶爾需陪同主管至工地現場口譯 3. 主管交辦事項
SHL Medical is the world-leading solution provider in the design, development, and manufacturing of advanced drug delivery systems with more than 5000 employees worldwide. Our customers include top pharmaceutical and biotech companies from around the globe that require innovative devices such as auto injectors or pen injectors to effectively deliver their drugs. Headquartered in Switzerland, SHL has sites in Sweden, Taiwan, and the Unites States. Job Overview 我們正在尋找數名撰寫風險管理檔案(RMF)的人員,你會頻繁的與客戶和內部設計及研發單位溝通合作,運用工程及法規的知識,以提供符合標準的RMF。 The role requires application of regulatory and engineering knowledge to deliver Risk Management Files (RMF) for the device designed and manufactured by SHL Medical. The candidate will work with customers and internal stakeholders such as Design and Regulatory Affairs (RA) team to outline SHL Medical’s risk management scope and deliver the RMF in compliance with but not limited to ISO 13485, ISO 14971, ISO 11608. Main Responsibilities • Participate in project intake activities to understand and assess feasibility of project proposals from risk management perspective. • Communicate and work together with customers and their representatives (clinical experts) to request and review Medical Harm List (MHL) that meets SHL requirements for intended device. • Initiate Risk Management Plan (RMP) and Hazard Identification Checklist (HIC) and align the overall risk management deliverables with internal stakeholders and customer. • Review D-FMEA and P-FMEA from design and risk assessment lead for content accuracy and the risk control measures applied for overall risk acceptance. • Attend relevant project meetings to ensure all information required to develop, update, and maintain risk management documents for related projects are captured and utilized effectively. • Participate in relevant product lifecycle management activities to provide/collect information and ensure RMF are updated periodically. Changes to RMF may be initiated by but not limited to change control, audits, design changes, regulatory requirements and customer request. • Participate in internal and external regulatory audits and inspections, including third party audits of product risk management and relevant design history files. • Ensure periodic review of post market data with supervisor and RA personnel to update device risk management file as needed. • Cascade any information from Risk Management File updates to risk assessment and project team to ensure concise communication and effective implementation of changes. • Where needed, participate and contribute on end-to-end device risk management process in SHL Risk Management improvement activities and gap remediations. • Escalate potential issues and changes that may impact device risk management files to related team members and participate in the recovery plans to ensure business risk and compliance risk are handled in timely manner. • Maintain periodic communication with customers to ensure engagement and information exchange between SHL and customer to maintain effectiveness and compliance of device RMFs. • Remain updated proactively with regulatory changes and compliance changes and escalate for discussion with Risk Manager to assess impact and changes required to risk management process and device RMFs. Skills and Qualification • Masters in Life Science Engineering discipline with 2 years of work experience (or) Degree with 5 years of work experience. Exposure to medical device, pharmaceutical or biotechnology industry is added advantage. • Trained on Quality System Regulation, Risk Management or Design Control courses. • Demonstrated and applied a broad knowledge in quality management assignments and risk management approaches. • Good communication and interpersonal skills and demonstrate ability to participate in inter-departmental projects and resolve quality-related issues in a timely and effective manner.