Responsible for the packaging site cGMP, record, and operation compliance, and elimination of potential risks. 負責包裝現場的cGMP、紀錄、操作的合規性，以及消除潛在風險。 Periodically review and revise the GMP documents(e.g., SOP, etc.) to ensure documentation compliance. 週期性審核GMP文件(如: SOP)以確保文件與流程吻合。 Involved in the cross-function optimization project to increase the process from the quality perspective. 參與跨部門優化專案以期從品質角度提升流程。 1. Responsible for the GMP operation effectiveness on the packaging production sites. 負責包裝現場的GMP操作有效性。 2. Responsible for the site work in progress and AQL sampling following appropriate specifications. 負責現場的製程間管控(IPC)以及AQL取樣符合規範。 3. To perform the line clearance confirmation to eliminate the mix-up risks. 執行清線確認以消除混批風險。 4. To perform periodic reviews of the GMP document for the packaging, provide and proceed to the optimization proposal about the detected gaps. 執行週期性包裝部門相關GMP文件審核，針對偵測到的流程不足提案/執行優化建議。 5 To govern and enforce the cGMP processes, 5S, implemented CAPA, and quality procedures are in place and follow

1. Review and enforce adherence to quality standards and agreements. 2. Manage non-conformance investigations and compliance. 3. Oversee GMP and regulatory compliance. 4. GMP Supplier Oversight: -Oversight the GMP Vender Audit Schedule. Ensuring Vendor and Auditor availability (internal/external/consultant) and confirming audit dates with both auditors and vendors. -reviewing supplier audit reports, ensuring they meet Lotus QA Standards and are compliant with Lotus SOPs. -Submitting observation reports to vendors, communicating response timelines and tracking them to ensure timely responses. Review of vendor audit responses and managing the review/editing cycle until responses are acceptable. Requesting documented evidence of closure when necessary and filing electronically and hard copy. 5. Manage quality assurance tasks including document control and investigations.

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. 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. Organize regulatory information and track and control submissions, review and advise on submission strategy for compliance with regulatory filings. 2. Evaluate new proposed change from operation team and assessment impact and requirement on regulatory filings worldwide, and research regulatory issues and provide guidance and advice to colleagues and RA team. 3. Ability to provide clear direction and guidance to RA teams and others. To organize, prioritize, and deliver tasks and projects, with a sense of urgency. Ability to organize team works in timely manner with accuracy. 4. Represent Regulatory Affairs on project teams to ensure all regulatory requirements are met throughout the product lifecycle. 5. Regular update RA status in order to align with business objectives, deliver outstanding launches. 6. Keep closer communication with marketing team and related department proactively to get correct and immediate updates of our products. Need to ensure the variation not disturb the inventory. 7. Effective in working with multifunctional team and to fix complex matrices. Strong communication, interpersonal, organizational skills and problem solving skills. 8. Ability to provide clear direction and guidance to RA teams and others. To organize, prioritize, and deliver tasks and projects, with a sense of urgency. Ability to organize team works in timely manner with accuracy. 9. Relocated in Nantou Operation Center for training for above 6months to a year.

This position will report to Tax Director of Lotus Group and be actively involved in tax planning, compliance, controls, and reporting with focus in South East Asia. As a key contact person for tax related matters in South East Asia, He/She is expected to maintain constructive relationships with representatives from the Tax Authority and tax consultants. e/She Role & Responsibility of regional tax role: -Manage tax compliance matters including but not limited to corporate income tax, indirect tax, withholding tax, local tax, tax provisioning, and tax accounting -Review and approve the tax returns or filings prepared by local finance or external advisors and ensure tax liabilities are paid in due course; -Partner and manage the relationship with various internal stakeholders such as Controller, FP&A, and functional heads to ensure all taxes (ie. current tax, deferred tax and WHT) are properly accrued and accounted not only for monthly reporting purpose but also for forecasting/budgeting. -Manage tax queries raised by tax office to ensure they are dealt with appropriately and on timely manner. If need be, seek advice from external consultants. -Highlight any contentious tax issues and suggest any practical solutions. -Support and/or educate local financial controllers with the changes in the domestic tax regulations that are impacting their business operations. -Actively support the Group Tax Director in developing the Group’s tax strategy as the business evolved including but not limited to -Assist Tax Director of Lotus Group in implementing strategic tax decisions that drives the Group tax forward. -Identifying opportunities for further enhancement and development of the tax strategy and function. -Proactively contribute ideas that could help to mitigate tax risks and/or optimize tax opportunities for the Group. Skills and Requirements -Bachelor's degree in any Accounting Field, preferred with CPA or tax related accreditation. -Minimum 10-15 years' experience within an international tax environment, ideally in the Big 4, preferably combined with a few years of in-house experience. Strong experience with a variety of tax operations (such as indirect tax, transfer pricing & tax accounting) and ability to drive process improvements. -Proficiency in Microsoft Office applications, especially Microsoft Excel and PowerPoint, working knowledge of some ERP system is preferred. -Ability to deal with multiple stakeholders across different cultures. -Ability to work independently without much supervision.

1. Prepare and execute process validation activities which includes development trials, troubleshooting and monitoring the process validation batches. 2. Lead cleaning development and validation activities for new products, equipment change and quality improvement. This includes preparation of change controls, cleaning development and validation documents, risk assessment, cleaning records and other associated documents as required. 3. Comply with GMP and EHS regulations 4. Other responsibility request by line manager.

1.應收帳款及銷貨收入相關帳務處理 2.業務相關費用審核 3.負責月結/報表編制及分析 4.其他交辦事項

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 operations. Support relevant departments and vendors to complete projects on time, ensure the work and analysis comply with GMP and SOPs. 訓練、領導並監督日常實驗室操作中的初級分析師。協助相關部門和供應商按時完成專案，確保工作和分析符合GMP和SOPs。 7. Review documents, prepare the analytical study report and CMC documents 審查文件，準備分析研究報和CMC文件 8. Responsible for establishing, maintaining, and updating the specifications and test methods for in-process and finished products in the pre-approval phase. 負責核准前半成品和成品試驗相關之檢驗方法與規格之制定、維護與更新。 9. Support assigned responsibilities to maintain GMP compliance of the chemical laboratory, as applicable. 依據分配責任，維持化學實驗室運作皆符合GMP規範 10. Promptly complete work and tasks assigned by superior 及時完成上級下達的工作和任務。 11. Support for analytical method transfer to analytical control, QP sites, and other receiving laboratories. 協助將分析方法轉移到分析控制，QP所在地和其他接收實驗室。 12. Cooperating with PD & RA, complete and all lab tests. 配合PD及RA完成各項化驗項目。 13. Ensure analysis can be conducted with efficiency and completed on time 確保分析工作得以高效率及迅速之進行。 14. Managing and maintaining instrument calibrations, laboratory instrument logbooks, and SOPs. 各儀器設備SOP之制訂、管理、定期維護、校正如期完成。 15. Ensure lab work is conducted according to SOP and complies with EU, US, JP, and global cGMP regulations. 確保其實驗操作皆依照SOP進行，並符合歐美日地區及全球cGMP之規定。

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