美時化學製藥股份有限公司

1. 負責大量文件掃描與品質檢查，並整理、分類及歸檔電子與紙本資料，確保紀錄完整與正確保存。 2. 蒐集批次及品質相關文件，確認資料完整與版本一致，並進行試算表編輯、格式統一及審查資料彙整。 3. 協助主管進行資料輸入、文件更新、表單準備，並提供其他行政支援。

1. 具備藥局相關業務經驗 2. 市場資訊收集分析、反對意見處理 3. 新開戶開發 4. 客戶分級及區域管理 5. 舉辦Seminar , RTD 6. 推廣及開發OTC指示用藥及處方藥物 *本職務實際業務責任區需依公司分配，以中部地區包含台中、彰化、南投為主。

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. 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. 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. Establish analytical methods of microbial and execute method validation to ensure analytical method accuracy. 2. Issue blank test report for conduct raw material/package material, semi- product/product and stability analysis, sampling and records, to ensure product quality meets PIC/S GMP requirements. 3. Review of project plans and analysis result reports, inspection/test reports, and SOPs. 4. Conduct test on water for production, Total organic Carbon of water system in laboratory systems and microbial test to ensure the quality of the water. 5. Conduct preparations of growth mediums and potency and growth tests of growth mediums to ensure microbial test run smoothly. 6. Conduct bacterial sub-culturing ,culturing, identification and counts to ensure microbial tests run smoothly. 7. Conduct environmental monitoring of production zones A,B and C(bacterial test on air conditioning system to ensure the conditions of production environment meets GMP requirements. 8. Conduct cleaning and maintenance of all instruments and equipment, calibrations/validations and sort yearly assessment reports to maintain normal usage of instruments and equipment. 9. Perform self-inspections or internal audits as required by the audit schedule.

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.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.藥品安全性監視計畫之執行及嚴重不良反應通報。 Execution of drug safety surveillance program and reporting of serious adverse events. 2.藥品/醫材上市後變更及展延送件 Submission of renewal and variations for drugs and medical devices 3.跨部門溝通 Work closely with project teams. 4.送件資料歸檔及維護 Maintain regulatory files/database and chronologies in good order. Establish and maintain system for tracking changes in documents submitted. 5.其他主管上級交辦事項 Complete assigned tasks