1. Per Each planning cycle to organize monthly sales forecast into campaign demand plan/bulk plan for production planning team to calculate the capacity requirement, material procurement plan and form the master schedule. 2. Prepare required data, challenge, reviews to report in monthly Domestic/Export S&OP meeting; confirming market demand with CS and Marketing team in the meeting. 3. Track demand forecast and sales/B2B order progress to ensure the supply schedule meets customer requirement. 4. Track production, testing and release progress to ensure the shipment schedule is followed. 5. New product launches-Ensure that all activities are aligned and provide timely submission of net requirements and orders. 6. Trigger escalation process as necessary. Identify and address potential supply issues pro-actively. Inform sales & marketing team on the potential supply risk timely. Recording all delay root cause for each shipment. 7. As Supply planner coordinate with demand planner, who oversees domestic market product, to manage local CMO PO Placement to meet inventory requirement. SPOC, escalation to TPP representatives for domestic TW CMO. 8. Intradepartmental communication and coordination and assisting in completing work assigned by superior.
1. Develop analytical methods, perform analytical tests, and assist the RD team in screening formulations for the NDA and ANDA drug development. 制定分析方法,進行分析測試,並協助RD團隊篩選用於NDA和ANDA藥物開發的製劑。 2. Follow laboratory SOPs and ensure GMP compliance. 遵循實驗室SOPs並確保符合GMP規範 3. Prepare technical documents and review data for the R&D projects and drug submission. 為研發專案和藥物開發準備技術文件並審查數據 4. Responsible for performing the R&D tasks and projects, such as analytical method development, method validation, formulation screening, raw material tests, finished product release, stability study, and dissolution testing.負責執行研發任務及專案,例如分析方法開發、方法確效、配方篩選,原料測試、成品放行、安定性研究和溶出度測試。 5. Use and maintain analytical instruments, GC, HPLC, UPLC,LC-MS Dissolution Tester, Titrator, Particle size analyzer, etc. Research, diagnose, troubleshoot, and identify solutions to resolve analytical instrument issues. 使用和維護分析儀器,GC,HPLC,UPLC,LC-MS溶出度測試儀,滴定儀,粒徑分析儀等。研究,診斷,故障排除和識別解決方案以解決分析儀器問題。 6. Train, lead, and supervise junior analysts in day-to-day laboratory opera
OVERALL OBJECTIVES: -Provide leadership and oversight of designated GxP Computerized Systems (that have are relevant for Lotus Pharmaceutical) and their support teams to ensure successful delivery of key objectives, as well as compliance with applicable business and regulatory requirements. -Work with teams to implement quality systems and improvements that meet local business and regulatory requirements. -Responsibilities include administration and management of the Electronic Document Management System (EDMS), Electronic Quality Management System (EQMS), Learning Management System (LMS), as well as extended support and oversight of other GxP systems. GENERAL DUTIES: -Ensure the following key areas of GxP computerized system governance are established and maintained for applicable systems -Management: Validation planning, supplier assessment, risk management -Development 1. Validation approach & deliverables – maintain current “as is” validation state 2. Configuration and design 3. Management, development, testing, and review of software 4. Data management -Operation 1. Support services, performance monitoring, incident management, security, training, user authorizations 2. CAPA, change management, updates/patches, repair activity 3. Data integrity, periodic review, backup and restore, business continuity -Quality lead on designated Computer Systems implementations, ensuring all regulatory and compliance issues are addressed and documented -Mentor staff working on GxP computer system validation -Lead and support improvement projects to solve problems, enhance system capabilities, and expand use of GxP systems to new sites and functional areas in need. -Work with relevant teams to maintain capabilities for collecting and reporting Quality data and projects, including maintaining Quality SharePoint Portals where necessary. -Participate in internal and supplier audits as requested. -Participate in improvement initiatives and programs as requested. -Stay current with GxP and industry standards QUALIFICATIONS: -Bachelor’s degree in pharmacy or life science, or higher degree, with the right combination of extensive experience and success in the pharmaceutical industry -Education in computer science, coding or programming is a benefit -Thorough knowledge of pharmaceutical industry, quality systems, computerized system validation, GAMP 5, and relevant GxP and data integrity requirements. -Experience and skills related to the operation, administration, and overall governance of GxP computer systems and software applications. -Working knowledge of help desk software/support, databases, SaaS, and analytical reporting -Strong technical background and ability to explain complex information in simple, clear terms to non-IT personnel. Ability to assess customers IT knowledge and provide appropriate support. -Proven track record of successful GxP Computer System implementations and governance. -More than 10 years’ experience in different quality related roles within the pharmaceutical industry -Good knowledge and experience in Project Management principles and techniques. -Thorough knowledge of Quality Systems and risk-based decision making. -Experience dealing directly with regulatory agencies -Experience and skills in operating across and between different national cultures. -Good command of Mandarin and English SKILLS: -Strong leadership/team management skills -Credible and confident communicator with good presentation skills (written and verbal). -Strategic thinker with the ability to influence at all levels -Strong analytical and problem-solving ability, including identifying potential solutions, recommending and implementing methods, procedures and/or techniques for resolution. -Able to work proactively and independently.
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.
幼兒園助理教師工作內容包含下列: 1.於班上協助老師教學及教保相關工作 2.隨娃娃車接送小朋友 3.協助辦公室行政事務 4.協助教學活動策劃與執行 5.其他主管交辦事項
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。
1.登記公司新進人員各項相關資料 2.處理員工請假、缺席、獎懲、獎金、薪給變更及其他異動資料 3.協助公司有關人事資料之查詢與答覆事項(熟悉國內勞動法令優) 4.郵寄信件、票據開立、銀行匯款 5.ERP系統資料處理 6.合約及文件資料檢查與更新 7.外籍人士相關業務辦理 8.其他主管交辦事項 9.每月需台北桃園往返(交通補助) 面試地址:桃園市平鎮區 平鎮工業區工業六路5號 工作地址: 桃園市平鎮區 平鎮工業區工業六路5號
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.無經驗可,要有一顆愛孩子的心,也願意學習。 2.協助幼兒學習自理生活。 3.維護幼兒在園所之安全。 4.協助娃娃車跟車及車上安全維護 5.協助班級進行課程活動
1.教導幼童良好的基本生活習慣,並保護幼兒在園內的安全。 2.鼓舞幼童自我表現及參與團體生活,以促進其社會行為之正常發展。 3.與家長溝通幼兒學習狀況。
1.教導幼兒良好的基本生活習慣和孩童生活事項處理,並保護其安全 2.設計安排幼兒說話、唱遊、舞蹈、美勞及戶外活動等課程 3.鼓舞幼兒學習如何自我表現並參與團體生活,以促進其社會行為的正長發展 4.與家庭、社區之聯繫,實地家庭訪問或舉行座談會,提倡親職教育,配合推展社區活動 5.校內生活環境管理(包含校內環境佈置…)、活動執行及機動支援
1.協助行政人員處理主管所交辦的其他事項 2.維護辦公室環境與設備之整潔 (視各公司規定) 3.負責平日零用金管理 4.協助會議、活動籌備、準備統計報表、書面報告、簡報等資料 5.公司文件檔案的建立及管理
1.電機工程重電設備安裝工作 2.現場工安措施預防 3.工程工安管理 4.工安文件書寫彙整
✤ 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 ✤ 需具ERP系統導入經驗2年以上
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。
1.協助開發高分子、橡塑膠材料製程 2.協助原物料評估及導入量產 3.製程改善、專案進度追蹤管理 4.協助測試資料整理與分析
1. 產品抽驗問題分析 2. 客訴問題溝通與分析 3. 協助主管規劃制度,並建立流程與管理 4. 推展各項品保工作以及安規執行與管理 5. 品管系統流程維護,協助持續改善,並提出執行所遇之問題供日後改進 6. 主管指定工作之推展