醫護非視不可專區

1.藥品調劑 2.藥物諮詢及衛教

1.照顧病患、協助服藥與衛生教育等護理臨床工作 2.記錄病患用藥記錄和各種病徵 3.輔助與安撫病患在治療過程中所產生心理上的不適，給予病患和家屬情感上適時援 4.行政管理業務 5.主（官）管交辦的事項

1.醫師處方之調劑 2.藥品管理 3.關心病人的用藥與病人溝通正確用藥知識

1.執行各病房外科病患傷口處理及換藥。 2.協助醫師手術進行。

1.護理相關科系畢業 2.有婦產科..小兒科門診護士經驗者佳 3.態度親切 , 服務熱忱 4上班時間為排班制..本院門診時間如下 上午9:00-12:00 下午3:00-6:00 晚上7:00-9:30 休假日:固定周日，其餘休假會排休

1.護理相關科系畢業 2.有婦產科..小兒科門診護士經驗者佳 3.態度親切 , 服務熱忱 4. 證照費另計

1.需具備藥師執照 2.具GMP藥廠經驗者佳

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、辦理職業安全衛生管理事項。 2、定期或不定期現場作業稽核或巡檢。 3、督導現場執行自動檢查。 4、每日施工前召開工具箱會議(TBM)實施工作人員勤前教育，並做預知危險(KY)、工作安全分析(JSA)。 5、執行IS45001相關活動。 6、其他主管交辦事項。

1. 協助醫師及診所其他作業 2. 掛號等行政工作 3. 具醫療知識

1.調劑醫師處方。 2.協助病患領藥。 3.協助賣場營養品、美妝品、婦嬰用品之銷售。 4.提供民眾得到正確的用藥常識或基本衛教知識。 5.整理相關健保申報之業務。 6.有藥局工作經驗者。

1.調劑醫師處方。 2.協助病患領藥。 3.協助賣場營養品、美妝品、婦嬰用品之銷售。 4.提供民眾得到正確的用藥常識或基本衛教知識。 5.整理相關健保申報之業務。 6.有藥局工作經驗者。

1.調劑醫師處方。 2.協助病患領藥。 3.協助賣場營養品、美妝品、婦嬰用品之銷售。 4.提供民眾得到正確的用藥常識或基本衛教知識。 5.整理相關健保申報之業務。 6.有藥局工作經驗者。

1.調劑醫師處方。 2.協助病患領藥。 3.協助賣場營養品、美妝品、婦嬰用品之銷售。 4.提供民眾得到正確的用藥常識或基本衛教知識。 5.整理相關健保申報之業務。 6.有藥局工作經驗者。

1.調劑醫師處方。 2.協助病患領藥。 3.協助賣場營養品、美妝品、婦嬰用品之銷售。 4.提供民眾得到正確的用藥常識或基本衛教知識。 5.整理相關健保申報之業務。 6.有藥局工作經驗者。

1.調劑醫師處方。 2.協助病患領藥。 3.協助賣場營養品、美妝品、婦嬰用品之銷售。 4.提供民眾得到正確的用藥常識或基本衛教知識。 5.整理相關健保申報之業務。 6.有藥局工作經驗者。

1.調劑醫師處方。 2.協助病患領藥。 3.協助賣場營養品、美妝品、婦嬰用品之銷售。 4.提供民眾得到正確的用藥常識或基本衛教知識。 5.整理相關健保申報之業務。 6.有藥局工作經驗者。