醫護非視不可

1.承攬商安全衛生管理(含協議組織推動)。 2.承攬商派駐。 3.職業安全衛生事項督導。 4.職安衛相關計畫訂定。 5.協助業主稽核輔導。 6.其他主管交辦事項。

執行長照2.0之居家服務範疇。 居家生活照顧、身體照顧服務、喘息服務，服務紀錄撰寫，參與會議。 包含身體清潔、基本日常照顧、餵食、協助沐浴及洗頭、陪同外出或就醫等。

執行長照2.0之居家服務範疇。 居家生活照顧、身體照顧服務、喘息服務，服務紀錄撰寫，參與會議。 包含身體清潔、基本日常照顧、餵食、協助沐浴及洗頭、陪同外出或就醫等。

1.依照長照2.0提供之居家服務項目(翻身、擦拭身體、更衣、扶持上下床、代購及陪伴) 等，為居家個案服務。 2.依照長照2.0提供之喘息服務項目(協助如廁、協助服藥、輔具協助)等，為居家個案服 務。

1.依照長照2.0提供之居家服務項目(翻身、擦拭身體、更衣、扶持上下床、代購及陪伴) 等，為居家個案服務。 2.依照長照2.0提供之喘息服務項目(協助如廁、協助服藥、輔具協助)等，為居家個案服 務。

1.依照長照2.0提供之居家服務項目(翻身、擦拭身體、更衣、扶持上下床、代購及陪伴) 等，為居家個案服務。 2.依照長照2.0提供之喘息服務項目(協助如廁、協助服藥、輔具協助)等，為居家個案服 務。

1.依照長照2.0提供之居家服務項目(翻身、擦拭身體、更衣、扶持上下床、代購及陪伴) 等，為居家個案服務。 2.依照長照2.0提供之喘息服務項目(協助如廁、協助服藥、輔具協助)等，為居家個案服 務。

1.依照長照2.0提供之居家服務項目(翻身、擦拭身體、更衣、扶持上下床、代購及陪伴) 等，為居家個案服務。 2.依照長照2.0提供之喘息服務項目(協助如廁、協助服藥、輔具協助)等，為居家個案服 務。

1.依照長照2.0提供之居家服務項目(翻身、擦拭身體、更衣、扶持上下床、代購及陪伴) 等，為居家個案服務。 2.依照長照2.0提供之喘息服務項目(協助如廁、協助服藥、輔具協助)等，為居家個案服 務。

1.依照長照2.0提供之居家服務項目(翻身、擦拭身體、更衣、扶持上下床、代購及陪伴) 等，為居家個案服務。 2.依照長照2.0提供之喘息服務項目(協助如廁、協助服藥、輔具協助)等，為居家個案服 務。

1.綜理居家服務各項業務。 2.擬定年度工作計畫、規劃安排各項教育訓練計畫。 3.機構評鑑準備及定期報表統計分析工作。 4.訂定居家服務標準作業流程、工作手冊及相關管理制度。 5.危機預防和風險管理，緊急情況處理和通報。 6.服務對象或家屬建議、申訴案件處理。 7.開展對外公共關係與參加會議。 8.服務滿意度調查及統計分析。 9.行政事務及文書處理。 10.其他上級主管交辦事宜。

1.綜理居家服務各項業務。 2.擬定年度工作計畫、規劃安排各項教育訓練計畫。 3.機構評鑑準備及定期報表統計分析工作。 4.訂定居家服務標準作業流程、工作手冊及相關管理制度。 5.危機預防和風險管理，緊急情況處理和通報。 6.服務對象或家屬建議、申訴案件處理。 7.開展對外公共關係與參加會議。 8.服務滿意度調查及統計分析。 9.行政事務及文書處理。 10.其他上級主管交辦事宜。

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

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.

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. 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

1.為病患翻身、捶背、擦拭身體、更衣、扶持上下床及散步等等 2.照顧病患飲食起居、服藥等等 3.打掃、整理環境、送洗病患衣物及代購所需用品

1.運用中國醫學方法，藉望、聞、問、切方式配合科學新知，診察人體各部所生之疾病，分析致病之原因 2.對症處方，運用方藥、手法、物理、針灸等方法，配合使用科學儀器及藥物，為患者作整體治療 3.提供有關中醫藥方面知識的諮詢

1.誠徵全職血液透析室護理人員，有血液透析經驗者尤佳，需具護理師或護理士證書 2.無經驗可或有意願學習血液透析專長者 3.固定休週日，週六及國定假日輪休，比照勞基法 4.意者電洽或寄履歷表:ysf0953822060@gmail.com

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