- 面議（經常性薪資達4萬元或以上） 台北市信義區 10年工作經驗 2天前更新展開
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.
- 面議（經常性薪資達4萬元或以上） 南投縣南投市 1年工作經驗 2天前更新展開
1. 制定/維護/更新使用於研發專案之臨床批及查登批的所有原、物料之規格及化驗方法。 2. 向原料及物料廠商索取相關文件，如：規格與檢驗方法、原料主檔案、技術文件等；審閱3. 廠商提供之技術文件，如有需要，進一步向廠商索取其他文件進行評估，做適當的整理與歸檔。 4. 協助CMC文件準備，提供主成分、賦形劑、包材之檢驗規格予法規部門，使其可進行NDA和ANDA查驗登記的文件整建作業。 5. 審閱B2B差異清單，並準備成本估算、工作計畫，並依據時程制定時間表，並及時協助B2B專案相關的客戶問題的完整回應。 6. 根據B2B需求準備和審核文件，例如檢驗規格、分析方法、標準操作程序等。 7. 按客戶要求準備CMC文件，使其可進行NDA和ANDA查登的文件整建作業。 8. 協助查廠時與實驗室相關之PIC/S GMP文件。 9. 查廠期間支援QA文件調閱與查核。 10. 主導變更管制之撰寫、偏差事件調查、矯正預防措施之評估與執行。定期更新、審閱及維護部門之標準操作程序。 11. 定期更新/採購各主要國家之藥典公定書。 12. 確保所有活動和分析均符合GMP、正確的程序、法規指南以及健康安全法規。
- 面議（經常性薪資達4萬元或以上） 台北市信義區 3年工作經驗 2天前更新展開
Overall Objectives Safety Officer, under the leadership of Lotus PVO (Pharmacovigilance Operations) Head, is responsible for execution of PVO activities in accordance with the Lotus pharmacovigilance quality system and local pharmacovigilance requirements. General Duties • Participates in or conduct daily PVO activities assigned by PVO Head • Maintains an accurate and comprehensive list of the Lotus products which are subject to pharmacovigilance activities by monthly alignment with the Regulatory Affairs teams • Coordinates with Local PV Offices (LPOs), PV CROs and partners or vendors regularly for PV activities • Monitors and tracks the PV activities performed by the stakeholders/LPOs, including, but not limited to: • Screening of local legislation and regulatory safety announcements, screening of local scientific journals for relevant safety information, as required • Maintenance of PV trackers (Individual Case Reports, Medical Inquiry and Product Quality Complaint, Aggregate Report tracker, Risk Management tracker, Safety Data Exchange Agreement tracker) • Updating of PSMF (Pharmacovigilance system master file) and relevant annexes as required • Reviews Individual Case Safety Reports (ICSR) and Medical Inquiries (MIs), as needed • Is aware of the risk management plans approved in their territory and of the risk minimization measures implemented. Assists in ensuring that the required activities are performed and tracked • Assist with the preparation and review of aggregate safety update report (PSUR, PBRER etc.) • Is aware of local safety concerns and supports the signal detection activities by reviewing the outcome of the screening of the local PV legislation and safety announcement, as required • Maintains and files the PV documents filed in the PVO specific folders (hard copy, where required and soft copy) • Coordinates for translation of PV related documents, when required • Tracks received adverse event, MI and PQC. Participates in reconciliation of PV activities between the Local PV Offices (LPOs) and PV CROs or partners or verifies that reconciliation activities are performed as per requirement • Supports in submission of relevant ICSRs received to competent authority within deadline • Participates in regular meetings with PVO and PV CRO as required and in-charge of MOM • Consults PVO Head for any issues or uncertainties relating to pharmacovigilance activities • Communicates with LPOs, PV CRO and other external PV vendors • Informs PVO when contacted regarding agreement involving pharmacovigilance obligations • Supports during audits and inspections • Trains on and applies the Lotus pharmacovigilance SOPs and the applicable PV related regulation • Stays current on the local PV legislation in the Lotus MA countries • Is involved during the development of Lotus pharmacovigilance SOPs • Ensures that all relevant employees in the LPOs receive basic pharmacovigilance training and that training is recorded and archived appropriately • Performs any other PV related activities assigned by the line manager (PVO Head) • Liaise with the stakeholder department or other internal departments.
- 月薪40000元 南投縣草屯鎮 3年工作經驗 2天前更新展開
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
- 面議（經常性薪資達4萬元或以上） 台北市信義區 5年工作經驗 2天前更新展開
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
- 面議（經常性薪資達4萬元或以上） 南投縣南投市 1年工作經驗 2天前更新展開
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.
- 面議（經常性薪資達4萬元或以上） 台北市信義區 工作經歷不拘 2天前更新展開
1、國際/國內永續ESG及公司治理資訊搜集與分析 2、利害關係人溝通：官網建置與更新、利害關係人需求回應 3、永續報告書編製並回覆國際永續評比 4、公益活動洽談及執行 5、公司永續目標進度追蹤 *本職缺為3~6個月短期約聘
- 面議（經常性薪資達4萬元或以上） 台北市信義區 工作經歷不拘 2天前更新展開
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
- 面議（經常性薪資達4萬元或以上） 南投縣南投市 5年工作經驗 2天前更新展開
1. Coordinate schedule, including meetings, appointments, and travel to ensure smooth running 2. Screen and manage mails and documents, and communicate with other departments and staff 3. Prepare presentation decks, materials and meeting minutes, and attend meetings as requested 4. Prepare and manage correspondence, and summarize documents 5. Maintain confidentiality of sensitive information 6. Handle and process documentation and other administrative tasks 7. Prepare reports, plans, and budgets for meetings
- 面議（經常性薪資達4萬元或以上） 南投縣南投市 2年工作經驗 2天前更新展開
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.
- 月薪31000~35000元 台中市潭子區 工作經歷不拘 2天前更新展開
1.執行疫苗或其他藥品無菌調劑/配製製程 2.生產線設備準備與操作、例行驗證與確效、第一級預防保養執行 3.作業環境無菌相關準備維護 4.原物料、設備等製程相關請領作業 5.修訂GMP規範相關文件與定期審閱 6.其他主管交辦事項 職缺頁面所列工作待遇為核定薪資 另有其他獎金、津貼，依實際工作狀況於核定薪資外另計（如排班津貼、職場津貼等） 並依生產狀況另提供生產津貼 上述獎金、津貼依公司規範章程現況為主
就業保險產假產檢假安胎假家庭照顧假 - 面議（經常性薪資達4萬元或以上） 南投縣南投市 3年工作經驗 2天前更新展開
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.
- 面議（經常性薪資達4萬元或以上） 南投縣南投市 5年工作經驗 2天前更新展開
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.
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