1.按照標準作業程序，執行清線/開線確認 2. 在開始生產之前，批准或驗收開機設定，然後開始生產，並在整個批次生產過程中將產品質量控制在規格範圍內。 3.在負責的生產線中，滿足預先計劃的生產計劃、生產目標，如生產周期、廢氣量、產量、品質目標和商定的供應計劃。 4.負責確保通過標準操作程序和批次生產記錄，按照品質標準和產品規格生產藥品，並確認覆核組員確實執行所有重要程序。 5.確保過程中的質量控制即時進行檢查和測試。 6.確保所有生產和品質以及製造記錄/文件均即時並精確地更新。 7.積極參與對半成品或製成品的所有主要和/或次要故障或不合格的調查，並確保採取商定的措施以防止其再次發生等。 8.訓練生產線組員正確的操作和清潔程序、材料申請，區域清理，結算程序，過程取樣檢查和測試，環境監控，cGMP等方面接受過正確的培訓 操作程序和批生產記錄。 9.確保現場工作人員遵守所有安全程序。 10.確保按照預定的時間表和標準操作程序進行環境監控。 加入我們的美時製藥產線團隊，讓您的技術熱情得到最大發揮！ 您將獲得製藥工藝和高品質生產技術的完善訓練及升遷制度，立即加入我們，美時是您製藥成就發展之路的唯一選擇！

1. Manage manufacturing process on the shop floor, handle accident events, and report to managers. Ensure production delivery meet KPI. 2. Oversee the technicians and ensure operations follow SOP, cGMP, and EHS regulations. 3. Recruit, probation, and performance evaluation of technicians, and oversee personnel training program execution. 4. Assist SOP generation/revision and investigation of customer complaint and deviation. In responsible area, manage all equipment, instruments, and tooling. Ensure the status of equipment/devices are ready for use. 5. plan and execute assigned projects. Other works assigned by managers.

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.

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. Facilitate the Lotus disposition process including: -Review of GMP Manufacturing Documents including Batch Records, Investigations, Deviations/CAPA, Analytical Testing Documents, and Certificates of Analysis. -Managing timelines and resources to ensure the disposition of material in accordance with Lotus‘ SOPs and within agreed timelines. 2. Support and ensures the successful day-to-day operations for the company. 3. Perform batch disposition activities in accordance with Lotus‘ SOPs and within agreed timelines. 4. Ensure the timely review of batch records, SOPs, investigations, corrective actions, change controls, technical documents, and adherence to Quality Agreements. 5. Ensuring that all work is performed safely, with quality, and in a timely, compliant manner. 6. Participating in continuous improvement projects throughout the group and the facility/operational portions of the organization. This includes all QA systems and pocesses as well as those on the shopfloor through the QA on the Floor functio

1.設計及安排說話、唱遊、舞蹈、繪畫及手工等學習活動，以促進幼兒身心的成長 2.教導幼兒良好的基本生活習慣，並保護其安全 3.鼓舞幼兒自我表現及參與團體生活，以促進其社會行為之正常發展 4.安排戶外學習活動，增進幼兒對大自然及社會環境的認識，引發其對周遭事物的關注與興趣

1.協助主管處理行政事務。 2.接待處環境清潔、安全、門禁之監督管理。 3.接待前來拜訪或參觀的人員，並提供諮詢服務。 4.製作帳務相關日報表事項 5.辦理現金及銀行往來事項、郵件工作 6.國稅局及財務報表資料彙整 7.車輛保險及維修管理等事項 8.水電、通訊設備的裝置及維護等事項 9.勞工局備查檔案等管理等事項 10.收發公文及補助款申辦作業 11.員工勞健保及團保相關事項

幼教新進人員面試須知 @考試後薪資為38000~45000 班老師/助理教師 1.協助幼兒學習自理生活。 2.提供幼兒日常生活（如：飲食、大小便等）的照顧。 3.維護幼兒在園所之安全。 5.配合幼教班與家長的需要，教授幼兒特殊課程，如：美語、繪畫、注音符號正音等。 4.配合幼兒發展狀況，設計、撰寫課程教案。 教保員 1.設計及安排說話、唱遊、舞蹈、繪畫及手工等學習活動，以促進幼童身心的成長。 2.教導幼童良好的基本生活習慣，並保護其安全。 3.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。 4.安排戶外學習活動，增進幼童對大自然及社會環境的認識，引發其對周遭事物的關注與興趣。 5.舉辦親子教學活動，或作家庭訪問，與父母共同討論幼童的行為表現與學習情形。

1.設計及安排說話、唱遊、舞蹈、繪畫及手工等學習活動，以促進幼童身心的成長 2.教導幼童良好的基本生活習慣，並保護其安全 3.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 4.安排戶外學習活動，增進幼童對大自然及社會環境的認識，引發其對周遭事物的關注與興趣 5.與父母共同討論幼童的行為表現與學習情形

幼教班老師/助理教師 1.協助幼兒學習自理生活。 2.提供幼兒日常生活（如：飲食、大小便等）的照顧。 3.維護幼兒在園所之安全。 5.配合幼教班與家長的需要，教授幼兒特殊課程，如：美語、繪畫、注音符號正音等。 4.配合幼兒發展狀況，設計、撰寫課程教案。 教保員 1.設計及安排說話、唱遊、舞蹈、繪畫及手工等學習活動，以促進幼童身心的成長。 2.教導幼童良好的基本生活習慣，並保護其安全。 3.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。 4.安排戶外學習活動，增進幼童對大自然及社會環境的認識，引發其對周遭事物的關注與興趣。 5.舉辦親子教學活動，或作家庭訪問，與父母共同討論幼童的行為表現與學習情形。

園長,主任: 1.大學畢業(幼教相關或資訊相關科系為佳) 2.負責行政相關庶務 3.協助教學保育相關業務 4.擅長電腦文書作業 5.具園所長證照

1..負責教學活動規劃與執行。 2.訂定教學目標、課程範圍、授課內容。 3.準備課程教材、課程資料以及課後作業等。 4.依據教學目標授課，並評估學生學習狀況以調整授課進度。 5.批改作業及測驗輔導。

*限幼教本科系**有經驗，薪40000起* 1.設計及安排說話、唱遊、舞蹈、繪畫及手工等學習活動，以促進幼童身心的成長 2.教導幼童良好的基本生活習慣，並保護其安全 3.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 4.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 5. 具美語基礎口語能力 6.表達清晰.溝通能力強.具親和力.

1.於學生上課前進行學生點名畫位 2.班級秩序管理 3.批改考卷、作業或聯絡本，協助出題、解題 4.補習班環境清理維護 5.安排學生補課事宜 6.協助招生相關事項 7.處理其他班主任交代雜項工作 8.考前加強

新進人員面試須知 @考試後薪資為30000~40000 1.協助班導師班務 2.校園環境清潔 3.配合學校活動