美時化學製藥股份有限公司

1. Facilitate Lot disposition process, reviewing GMP docs and managing timelines. 2. Support day-to-day Quality Assurance - Operations. 3. Perform batch disposition activities within specified timelines. 4. Ensure timely review of batch records, SOPs, investigations, and adherence to quality agreements. 5. Set meaningful goals, metrics for groups, and manage performance. 6. Ensure safe, quality, and timely work. 7. Participate in continuous improvement projects, including QA systems and shopfloor processes. 8. Manage non-conformances investigation and compliance. 9. Ensure quality production and operation in accordance with schedule. 10. Quality Assurance management, covering documentation control, batch record review, investigations, production support, training, and compliance initiatives.

1.開發調整分析方法(HPLC, GC, IC...)，協助產品製程開發，分析方法之確校 2.執行實驗室設備3Q 3.研擬審查藥典相關產品規格及分析測試，建立藥典規格 4.操作化學分析儀器進行分析，協助產品放行

1. Facilitate Lot disposition process, reviewing GMP docs and managing timelines. 2. Support day-to-day Quality Assurance - Operations. 3. Perform batch disposition activities within specified timelines. 4. Ensure timely review of batch records, SOPs, investigations, and adherence to quality agreements. 5. Set meaningful goals, metrics for groups, and manage performance. 6. Ensure safe, quality, and timely work. 7. Participate in continuous improvement projects, including QA systems and shopfloor processes. 8. Manage non-conformances investigation and compliance. 9. Ensure quality production and operation in accordance with schedule. 10. Quality Assurance management, covering documentation control, batch record review, investigations, production support, training, and compliance initiatives.

1.開發調整分析方法(HPLC, GC, IC...)，協助產品製程開發，分析方法之確校 2.執行實驗室設備3Q 3.研擬審查藥典相關產品規格及分析測試，建立藥典規格 4.操作化學分析儀器進行分析，協助產品放行

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 function

Responsible for procurement data related to cost analysis, system SME (SAP S4 HANA). Support Procurement Team for spending analysis, set up procurement strategy, and prepare all reports (such as cost saving report, tracking of KPI, Process flow) to allow procurement functions for strategic and systematic operation. Responsibilities include but not limited to: -Generate data for historical systems and cross functions (Procurement, Finance, SAP, HANA, CAR) Power BI Report development. -Build Analysis Services reporting models. -S&OP Support: Carry out purchasing delivery tracking systematically for procurement team to ensure accurate delivery and avoid lack of material. -Improve Cost analysis report and maintain process through data analytics (templates, configurator) -Develop visual reports, KPI scorecards, and dashboards using Power BI desktop. -Responsible for designing methodology and project documentaries. -Power user / SME of SAP, BPM of Lotus all ERPs system -Prepare reports, plans, and budgets for meetings -Handle and process documentation and other administrative tasks -Work at Nantou site at least 2-3 days per week

Managing the Procurement activities and all related activities regarding Indirect Materials, Packaging Materials, Capital, such as strategic sourcing, commercial negotiations, contract administration, and supplier relationship management. 1. Executes the Company's Procurement Strategy 2. Responsible and accountable for achieving targeted results, including cost savings 3. Utilize should-cost models for assigned categories that are benchmarked and relevant to the global marketplace 4. Provide market intelligence and price trends to relevant internal stakeholders on a disciplined schedule 5. Lead on sourcing events/RFQ process and ensure the company's needs for the materials/service in the category managed are supplied at the right time, in the right quantities and at the right price 6. Build and maintain strong and fair relationships with all external suppliers and all internal stakeholders 7. Develop a contract strategy for each project, including to create, negotiate, monitor and enforce contracted terms and conditions 8. Collaborate internally to drive and develop key performance measures/metrics for Strategic Suppliers and monitor supplier performance against these expectations to ensure continuous supplier improvement 9. Enlist senior management, when appropriate, to help reinforce commitment and involvement from suppliers 10. Develops and maintains a strong supply market knowledge 11. Work at Nantou Site 2-3 day per week

1. Provide direct supervision, coaching and mentorship of staff 2. Assist management with the accountability for the overall success deliverables to support the company’s critical and strategic business plan, goals, and objectives. 3. Develop and manage budgets, staff performance program and key scorecard. 4. Direct the activities of all functions involved in the planning, warehousing and control of materials from the receipt of forecasting replenishment needs to the delivery of the finished product to customers. 5. Management of capacity planning to meet business objectives. 6. Proactively planning for all contingencies that could affect the product supply plan. 7. Establish annual goals and objectives, including stretch targets, in coordination with corporate objectives, and manages performance to ensure attainment. 8. Develop and achieve the annual budget of planning department. 9. Manage the center of excellence of all planning systems such as SAP. Ensure the Master Data and BOM’s for the SAP system are kept current. Develop the production standard in SAP for the new products. 10. Participate in exiting and new product planning processes to assure timely acquisition of materials to support product launches. 11. Manage inventory and establish controls to ensure site is operating at the highest level of performance based on key performance metrics and minimized supply chain risk. 12. Comply with Safety & compliance: -Support and enhancing the quality compliance systems to ensure the required documentation and training is prepared and implemented effectively (i.e. SOPs, Investigations, CAPAs, etc.) -Ensure that employees are trained on all required GMPs and SOPS for their roles. -Support the quality and compliance initiatives through active communications with department management and employees. -Review and develop all necessary departmental SOPS and policies and review with the Quality function. -Maintain compliance with all regulatory requirements and ethical standards related to procurement. -Lead and coach others in maintaining excellence on cGMP, quality and safety. 13. Report: -Develop long range production and capacity plans, advises the management team regarding manufacturing capacity needs and take actions to implement agreed upon plans. -Track and report on appropriate performance metrics. -Publish department's progress status updates, production plan performance metrics and department's KPI.

1. Provide leadership and manage the work activities of direct reports in the area of application development for Commercial-off-the-Shelf applications that includes new solutions and enhancement of existing applications 2. Collaborate with business and key IT stakeholders to plan, prioritize, and schedule applications development and enhancement requests, while providing direction and guidance to the applications development staff 3. Accountable for availability and performance of applications portfolio, including ownership of incidents and release management 4. Drives stakeholder satisfaction by delivering quality applications and support with controlled and planned change management and communicate project status to various levels of management 5. Partner with leaders of other disciplines to ensure proposed solutions align with information, technology, infrastructure, business and security architectures 6. Provide oversight in standards adherence through reviews of project work including detailed technical specifications and application code 7. Proven experience in managing relationships with vendors/consultants, IT teams and internal stakeholders 8. A passion for all things tech and a drive to experiment with new technologies to see where they can benefit the business and staying hands-on technical as well as wearing that team management hat

1.協助主管規劃廠房、設備、生產、Artwork、品質制度等運作落實，以提昇部門績效。 2.協助各類專案之規劃與執行。 3.完善人才培訓體系及晉升發展管道。 4.100％藥廠CGMP訓練。

※※※擴大徵才，工廠提升計畫完工，製藥產線擴大生產規模※※※ 依廠內標準作業程序和現行GMP規範，按排程和製造批次執行產品製造，工作內容包含： 1. 負責執行產品生產相關工作 2. 負責執行產品之製造 3. 負責生產進度及狀況，確實填寫批次記錄及相關表單 4. 執行設備及工作環境清潔及維護 5. 製程設備操作 (混和、打錠、造粒、充填、熔膠、壓丸、定型乾燥等)及相關GMP文件記錄填寫 6. 包裝機台操作(片裝、瓶裝、盒裝、裝箱等)及相關GMP文件記錄紀錄填寫 7. 其他主管交辦事項 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. 根據生產計畫及需求，準確領取並準備生產所需的原物料。 2. 依照標準作業程序(SOP)進行物料分裝與標示，確保物料準確無誤。 3. 確實填寫物料領用、退料及報廢紀錄，確保文件完整可追溯。 4. 遵守工廠安全規範，確保作業過程符合環安衛標準。 5. 協助主管處理臨時交辦事項，如設備保養、異常處理等。

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.

OVERALL OBJECTIVES To create, update and perform tasks against pharmaceutical artwork following strict Lotus guidelines and procedures. To communicate in an effective manner with all main stakeholders in order to achieve timely signoffs of artwork. To act as mediators between Artwork Technicians and suppliers to ensure that all technical elements of the artwork are processed in a standard way. GENERAL DUTIES • Responsible to ensure that artwork is processed within defined timeframes and following the most up to date guidelines and quality checks. • To liaise with local Regulatory teams to ensure that timelines are met and workflows do not become stagnant. • To liaise with suppliers in order to collect technical approvals for artwork, ensure correct transmission of print-proofs, and deal with all required supporting documentation required to complete artwork. • To follow QMS procedures and ensure that compliance actions are completed within timelines and are recorded appropriately.

Summary: -Ensure compliance of HR activities. -Manage appropriate compensation & benefits structure and system to facilitate performance-oriented culture and to attract and retain talents. Responsibilities: 1. Devise initiatives and facilitate related activities to bring positive impact on talent retention and performance driven culture. 2. Ensure the holistic C&B related policies are available and maintain appropriately 3. Facilitate to align consistent C&B related communication which is in line with management directions across the organization 4. Manage labor cost appropriately thru logic data analysis. 5. Take initiative to analyze HR data from various aspects to optimize C&B activities. 6. Ensure the accuracy of C&B related data and timely. 7. Facilitate to deal with employee issues appropriately. 8. Ensure company activities in line with labor related regulations. 9. Continuous optimization of compensation and benefit activities.

-Employee onboarding process administration -HR system administration -Ad hoc HR projects

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. 協助對內、對外溝通資料彙整 2. 對外溝通簡報設計 3. 公司社群媒體圖像設計製作及文字編撰 4. 協助執行公司官網建置設計與更新、利害關係人需求回應 5. 熟悉 Photoshop / Illustrator 軟體佳 *本職缺為3~6個月短期約聘

1. The ability of IP risk assessment and Freedom-to-operate analysis in US, Europe, and Taiwan to support the development of new products. 2. The ability of trademark evaluation in Taiwan, China, Hong Kong, Singapore and assist in applying trademark applications in countries. 3. With a patent invalidity search skill for challenging patent's validity in Europe, Taiwan and give analysis for scientific IP strategies. 4. Oversee the litigation and opposition cases in TW to ensure that work meets quality, timely reply to official communications within the due date and budget control as agreed among the legal agencies. 5. Technical expertise with legal proficiency and strong communication skills.

※※※ 感謝您對美時製藥的關注 ※※※ ★欲了解目前開放的工作機會，請參考 104 人力銀行上的各職缺詳細說明★ 此為集中媒合專區，只要對Lotus美時製藥職缺有興趣，歡迎持身心障礙手冊朋友主動投遞履歷，應徵者請以104系統投遞履歷，並請在個人履歷上註明「欲應徵的職務」，若適合職務需求將有專人根據個人專長進行職缺媒合，並主動聯繫通知後續面試安排。 如未接獲通知，表示暫無適合的職缺，恕不另行通知。參與面試者，面試時需檢核身心障礙證明文件。 ◆歡迎推薦身心障礙朋友投遞本公司履歷◆