- 月薪29000元 高雄市左營區 工作經歷不拘 1天前更新展開
電視.廣播與網路廣告之自有品牌. !!高額月薪絕不是夢!! 1.保障底薪+高額績效獎金(超過政府基本底薪規定) 2.二個月上手.四個月穩定.六個月達人. 3. 完整S.O.P.教育訓練培育訓練. 4.知名品牌,最高底薪+高額獎金. 5.巨蛋捷運站.交通便利. 享公司完整福利 1.週休二日,無須加班 2.上班時間AM9：00~12:00~PM13:00~17：30 午休一小時 3.享勞、健保、勞退 4.三節禮金或贈品 5.年假比照勞基法 名額有限~剩餘4名額.還在等什麼~歡迎您加入我們的行列!!!
就業保險產假產檢假安胎假全勤獎金 - 面議（經常性薪資達4萬元或以上） 台南市仁德區 1年工作經驗 3天前更新展開
1.製造過程中之製程巡檢、實施品管計畫 2.原物料、半成品，成品、包裝、出廠之品質檢驗以及判定 3.各項品管圖表之繪製以及標準樣本之製作 4.製程管制，掌握品質變異狀況，解決問題，負責產品品質水準之穩定 5.灌輸作業員品質觀念，教導其使用簡易品管技術 6.不合格品原因之追查、分析、報告以及處理 7.溝通協調及人員培訓
年節獎金分紅入股員工生日禮金年終獎金壽險 - 面議（經常性薪資達4萬元或以上） 台南市安南區 3年工作經驗 今天剛更新展開
稽核人員具備下列條件之一： 1.擔任公開發行公司、證券或期貨相關機構之稽核人員滿二年以上者。 2.於符合「會計師辦理公開發行公司財務報告查核簽證核准準則」 （以下簡稱查簽準則）第二條所定之聯合或法人會計師事務所從事審計工作滿二年以上者。 3.具有公開發行公司之業務工作經驗滿三年以上者。 4.具有電腦程式設計師或系統分析師等專業工作經驗滿三年以上者 5.取得會計師考試及格證書、國際內部稽核師協會所核發之國際內 部稽核師證書或國際電腦稽核協會所核發之國際電腦稽核師證書者。 二、公開發行公司於聘任新進內部稽核人員時，其資格條件應符合前述規定。 三、工作內容 1.建置及維護內部稽核制度，協助各部門修訂內控文件。 2.配合會計師及主管機關內控查核作業。 3.依據年度稽核計畫執行稽核作業及追蹤異常事項之改善進度。 4.辦理定期內部控制自行評估規劃及覆核。 5.主管機關規定之公告申報作業及法令作業(上櫃公司應辦事項一覽表)。 6.協助董事會、股東會事務與其他各項法規遵循與監督。 7.推動、溝通、協調及解決各部門間之流程及作業問題。 8.協助ESG永續報告書。 9.其他主管交辦事項。
產假產檢假年節獎金員工生日禮金年終獎金 - 面議（經常性薪資達4萬元或以上） 台北市信義區 2年工作經驗 10天前更新展開
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
- 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 10天前更新展開
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.
- 面議（經常性薪資達4萬元或以上） 台北市信義區 6年工作經驗 10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. 7. Will be providing presentations and workshops.
- 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 10天前更新展開
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
- 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 10天前更新展開
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.
- 面議（經常性薪資達4萬元或以上） 南投縣南投市 10年工作經驗 10天前更新展開
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.
- 月薪37000~70000元 南投縣南投市 工作經歷不拘 10天前更新展開
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
- 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 10天前更新展開
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.
- 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 10天前更新展開
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.
- 時薪190~200元 台北市士林區 半年工作經驗 3天前更新展開
1. 接待顧客、介紹商品。 2. 環境整潔、鏡框擺設。 3. 協助門市結帳、店務作業。 4. 檔案文件管理。 5. 維持環境與設備之清潔與維護。 6. 協助拍攝產品。
全勤獎金年節獎金員工生日禮金年終獎金三節獎金 - 月薪29000~33000元 高雄市路竹區 工作經歷不拘 4天前更新展開
1.環境整理 2.每日設備操作回報 3.例行性巡檢紀錄抄表 4.水措設備操作維護 5.水質檢驗 6.填寫操作紀錄 7.其他主管交辦事項
年終獎金三節獎金國內旅遊尾牙員工在職教育訓練 -
