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第 1 頁
4/21
本職缺為杏輝集團聯合招募,係屬杏輝藥品工業股份有限公司員工, 其職務內容為如下述,歡迎法務相關背景人才加入,應屆畢業生亦可。 1.執行中英文契約之審閱、修改、撰擬 2.撰寫法律文件(存證信函、訴狀) 3.提供各類法律諮詢意見 4.公司營運相關法規遵循追蹤及處理有關紀錄和文件,以確保作業程序及合規 5.研究分析並撰寫有關法律相關之報告 6.公司法律教育訓練內部(個資、營業祕密、IP)講師 7.處理公司訴訟、仲裁或其他爭議事件及擔任公司與外部律師聯繫窗口 8.其他法務案件或主管交辦事項
積極徵才中
應徵
4/21
帳務助理工作主軸為公司帳務系統登打等,分述如下: 1.輸入、處理並追蹤客戶訂單,並將訂單資料存檔,確保資料準確無誤。 2.負責帳務類文書資料編制處理及歸檔工作。 3.管理發票開立事宜,依據公司需求完成相關工作。 4.定期提供業務銷售狀況報表,以供業務人員或主管參考。 5.協助業務人員處理銷售業務相關之公司內部行政作業。 6.協助業務人員整理客戶資料(如:公司基本資料、交易記錄、問題處理狀況)。 7.其它主管交辦事項。
積極徵才中
應徵
4/21
開發及經營藥局通路,包含: 1 負責所屬區域客戶經營與產品業務推廣,業績目標達成與客戶開發; 2 推廣現有產品、操作listing以達成年度區域業績目標; 3 客戶訴怨處理、應收帳款管理、反應市場與客戶訊息並回饋內部; 4 配合部門主管交辦事項; *月薪包含交通津貼,油資補助另計。
積極徵才中
3 天內聯絡過求職者
應徵
2/21
As QC Microbiologist major responsible as below: 1:參與潔淨系統監測和微生物實驗室的測試,並確保監測和測試操作符合。PICS/GMP和中裕新藥QMS的要求。 Participate in
應徵
3/10
奈米化藥物劑型研發,藥物奈米化技術平台開發,及其它交辦的各項工作。 【Description】 Formosa Pharmaceuticals seeks an independent, motivated, and team-oriented researcher to learn and implement our proprietary APNT® formulation technology and join the team in Taoyuan. The successful candidate will be passionate about contributing to our ongoing growth and success. 【Responsibilities】 1. Develop and optimize APNT@ and pharmaceutical nanoformulations. 2. Practical implementation of drug delivery and formulation techniques for the purpose of generating novel and/or enhanced drug candidates. 3. Understand project strategy and work toward achieving company goals 4. Regular submission of progress reports and summaries 5. Prepare technical documentation for communication, including transfer and validation of pharmaceutical manufacturing processes. 6. Maintenance of a detailed lab notebook and clean lab bench/hood area 7. Foster teamwork, contributing to a positive and collaborative environment with employees both within and outside the group 8. Involvement in cross-functional aspects of projects and assist in the completion of any required tasks. 9. Report to Staff Scientist or Director of Nanotechnology 【Technical requirements】 1. Understanding of GMP regulations and extensive experience in pharmaceutical analysis techniques. 2. Experience in the usage of drug delivery and formulation techniques and instrumentation 3. Knowledge of biological consequences related to formulation is a plus.
積極徵才中
1 天內聯絡過求職者
應徵
3/10
【Position Summary】 Formosa Pharmaceuticals is a biopharmaceutical company operating in the areas of ophthalmology, oncology, and anti-infectives. We are seeking a Quality Assurance Supervisor to join our team. The successful candidate will lead the Quality Systems for the company’s programs and interact with external vendors, customers, partners, and regulatory agencies. Clear, concise, and effective communication skills in English speaking and writing are essential. Title and salary are commensurate to level of experience. For more information about our company, please visit our website at: https://www.formosapharma.com/. 【Job Responsibility】 -Develop, maintain, and enforce comprehensive quality agreements with the CMO and regional partner to define roles, responsibilities, and expectations. -Conduct or participate in regular GMP audits at CMO to ensure compliance with current GMP requirements. -Review and approve batch production records, CoAs, and deviations before product release. -Assist the CMO in reviewing, investigating, and approving deviations, and ensure effective implementation of corrective and preventive actions (CAPAs) -Monitor and approve any changes to processes, equipment, raw materials, or procedures that may impact product quality. -Collaborate with the CMO to investigate product complaints and implement resolutions to prevent recurrence. -Assist the CMO during regulatory inspections and provide necessary documentation or clarifications to authorities. -Provide training to enhance the team’s expertise in quality management. -Maintenance GDP license -Manage SOP and GMP/GDP related documents within the company -Oversee operational safety and health matters. 【Technical requirements】 -Stay current with global quality standards and guidelines -Generation and review of quality reports and presentations -Experience with Quality Management Systems and tools 【Minimum Qualifications】 -Bachelor’s Degree in science-related field with 3+ years’ experience in Quality Assurance and Systems in a pharmaceutical setting. -Strong understanding of Quality System, pharmaceutical/GMP, and ISO guidelines; -Auditing experience -Excellent interpersonal and communication skills, including written and spoken English and Chinese, in an individual or team setting 【Required application material】 -CV with detailed description of QA experience -References with contact info is appreciated
積極徵才中
應徵
4/22
1. 製程研究改善事項。 2. PIC/S GMP生產主管及製程開發工作、PIC/S GMP查廠相關作業及執行。 3. 製程相關確效規劃及執行。 4. 無菌作業程序及制度、所有設備使用及清潔之標準。 5. 其它主管交辦事項。
應徵
4/22
1. 負責變更管制案件處理以及追蹤。 2. 負責偏差調查以及矯正預防措施處理以及追蹤。 3. 撰寫品質部門GMP文件包含確效/驗證文件、標準作業程序等。 4. 管理校驗證系統。 5. 執行品質系統稽核工作。 6. 執行主管交辦事項。
積極徵才中
1 天內聯絡過求職者
應徵
4/15
1. 執行細胞株遴選/安定性/凍存/培養等相關實驗。 2. 開發重組蛋白和抗體哺乳細胞培養生產與收穫製程。 3. 撰寫製程開發、製程描述、與製程技術轉移相關文件。 4. 撰寫製程確效相關文件與報告。 5. 分析生產製程與數據,執行 Gap分析和風險評估 (FMEA)。 6. 與生產、下游製程開發、或外包製造單位密切合作導入與優化製程。 7. 支援 IND/BLA 相關文件撰寫 (上游部分)。 8. 需配合實驗平假日加班。 9. 執行主管交辦的其他任務。
應徵
2/14
- 負責廠內設備校正排程、預防保養排程、圖說管理、矯正維修工單管理,系統報表管理工作。 - 協助將已完成的驗證文件歸檔。 - 協助維護設備確效狀態,確定設施或設備符合GMP規範。 - 協助部門內採購相關作業。 - 支援部份工程單位工作。 - 主管交辦事項。 - 協助偏差調查、稽核缺失改善。 - 諳英文,說、寫 溝通能力。
應徵
2/14
• 公用系統(空調系統、鍋爐、壓縮空氣、製程氣體、WFI、廢水系統)儀表校正、維護保養、再驗證、故障排除 • 中央監控系統(EMS、BMS)操作維護(包括無塵室警報處理) • GMP相關文件撰寫、歸檔 • 配合廠商施工保養,確保施工品質符合要求 • 需配合假日值班及夜間警報、突發狀況緊急處理 • 其他主管交辦事項
積極徵才中
應徵
4/22
1. 負責生產所需原料、物料均依照GMP規範管理 2. 負責管理倉庫物料,制定標準作業規範及文書作業 3. 負責生產所需之原物料 4. 收發貨、雜項請購、協助配合生物管工作事項 5. 未來可培訓生管工作 6. 其他主管交辦事項
積極徵才中
2 天內聯絡過求職者
應徵
4/22
1. 微生物檢驗分析 2. 理化檢驗分析 3. 理化實驗機台操作(IC、GPC、UV、HPLC、GC) 4. 主管交辦事項 ▲具微生物檢驗相關經驗者優先考慮
積極徵才中
21 小時前聯絡過求職者
應徵
4/09
經常性事務 1.參與臨床試驗相關計畫送審、執行、追蹤。 2.整理篩選試驗適合執行廠商及相關之合約與經費協調、試驗文件準備。 3.協助試驗監測訪視、試驗執行進度管理、試驗資料整理、確保試驗執行符 合 GCP、計畫書與相關法規規定。 4.追蹤產業發展和新的法規要求,確保團隊具備最新的臨床試驗知識和技 能。 5.執行與追蹤臨床前藥理專案、搜尋及彙整相關文獻與數據。 6.落實公司研發相關法規申請、採購行政業務。 7.執行主管交辦其他事項與跨部門溝通。 非經常性事務 1.各專案預算編列與規劃執行。 2.協助盤點與管理藥品庫存。 3.研發相關會議安排與執行。 4.執行與協助其他部門支援事項。
應徵
4/09
經常性事務 1.建立並完善藥材與原料藥品質保證體系(製程、CMC 與 GACP 製造文件),並編制相應之文件和標準,落實相關文件之審閱。 2.管理與規劃藥材與原料藥檢測、評估、監控工作,及時處理藥材與原料藥異常問題,確保交付品質。 3.追蹤藥材、原料藥與原物料進/出貨、驗收/退、檢驗作業,不合格之原因追查、分析與報告撰寫並呈報。 4.落實倉庫管理(盤點、規劃標示與位置),以確保庫存安全及製造庫存量。 5.確認法規更新,並同步更新原物料規格。 6.管理與追蹤活性檢驗/劑型之委外研發、製造之委外代工及 CMC 相關委外檢驗等專案。 7.執行主管交辦其他事項。 非經常性事務 1.編列各專案預算與規劃執行。 2.維護設備與清點。 3.執行與協助其他部門支援事項。
應徵
4/15
Job Description: The GMP Manufacturing Facility Site Head will lead TaiMed’s monoclonal antibody cGMP manufacturing organization to produce clinical and commercial products across the manufacturing network. The position also oversees the newly formed CDMO business. This role is responsible for developing manufacturing strategies and executing operations to ensure financial, timeline, and quality objectives are attained. The leadership role manages all aspects of manufacturing operations, including material management, manufacturing, quality assurance, quality controls, facility engineering, and production planning. This position will report to the CEO. Due to the nature of manufacturing, the qualified candidate prefers to be a subject matter expert in cGMP manufacturing. Primary responsibilities of the role: • Manges cGMP manufacturing conducted at internal and external cGMP manufacturing sites • Provides leadership for the cGMP manufacturing functions, including process development, manufacturing, material management, quality assurance, quality controls, facility engineering, and CDMO business. • Manages CMO business and is responsible for negotiating service/supply agreements, SOWs, and master service agreements • Manages budget and resources related to the cGMP manufacturing network • Ensures manufacturing compliance with regulatory and cGMP standards Qualification: • Master or Ph.D. in biologics, engineering, pharmaceutics, or related science fields. Ph.D. is strongly desired • Minimum of 10 years of experience in leading cGMP manufacturing operations of biologics and/or pharmaceuticals • Experienced in leading a cGMP manufacturing site and familiar with people, operation, priority, and budget management, is highly desired • Working experience in regulatory filings (IND, BLA, MAA) and cGMP inspections by regulatory authorities • Demonstrated leadership capability and track record of developing and leading high-performance teams and organizations • Ability to work successfully in a small organization • Extensive technical experience in process technical transfer, scale-up, qualification, validation, and commercial operations • Demonstrated problem-solving skills and strong organizational skills • Experienced in managing CDMO business with respect to negotiating contracts and preparing SOWs and master service agreements • Outstanding written and verbal communication/listening and presentation skills About TaiMed Biologics TaiMed Biologics, founded in 2007, is a leading biopharmaceutical developer and manufacturer in Taiwan. We have extensive monoclonal antibodies (mAb) development and manufacturing experiences. We have successfully developed and commercially launched the first and only mAb for HIV treatment in the US and Europe (Brand name: Trogarzo®). Leveraging our extensive experience and cGMP facility, we also offer Contract Development and Manufacturing Organization (CDMO) services for biopharmaceutical companies to propel important monoclonal antibody molecules from development to market launch.
應徵
4/22
1. 依據最新的藥典定期更新廠內原物料及產品檢驗方法及規格 2. 原物料進料檢驗 3. 產品相關的放行檢驗 4. 執行分析方法確效 5. 撰寫及修改實驗室SOP 6. 實驗室儀器保養維護 7. 非無菌產品微生物檢驗以及環境監控、水系統水質監控 8. 審閱品管實驗室檢驗報告 9. 協助品管實驗室OOS及偏差調查 10. 管理品管實驗室以及安排檢驗時程 11. 主管交辦事項
17 小時前聯絡過求職者
應徵
3/10
【Position Summary】 Formosa Pharmaceuticals is a biopharmaceutical company operating in the areas of ophthalmology and oncology. The Company is seeking a Research Assistant, Associate, or Scientist to join our dynamic team at our Taoyuan offices. The successful candidate will play a key role in managing and coordinating the preclinical and IND (Investigational New Drug)-enabling development of novel biologics, supporting their progression along the clinical development pathway. This position is ideal for individuals passionate about cutting-edge antibody-drug conjugate (ADC) research, eager to contribute to a start-up environment, and looking to make a real impact in drug development. Clear, concise, and effective communication skills in English speaking and writing are essential. Title and salary are commensurate to level of experience. For more information about our company, please visit our website at: https://www.formosapharma.com/. 【Job Responsibility】 • Design, review, and contribute to study protocols, analytical methods, and batch records. • Work both independently and collaboratively within multidisciplinary teams. • Manage and oversee research projects, coordinating with internal teams, CMOs, CROs, and external partners during preclinical and clinical activities. • Prepare and review study reports, regulatory documentation, and patent applications. • Present project updates and findings to the management team. • Provide support to team members as needed and contribute to various company initiatives. • Take on additional responsibilities as assigned to support company growth and innovation. 【Technical requirements】 The list below is representative of the knowledge, skill, ability, or personal attributes required to be an ideal candidate: • Understanding of bio-analytical or bio-processing tools; hands-on experience is an advantage. • Familiarity with animal studies in pharmacokinetics, pharmacodynamics, and toxicology; hands-on experience is a plus. • Strong academic English skills, both written and verbal. • Detail-oriented, adaptable, and proactive with a strong problem-solving mindset. • Understanding of Quality System, pharmaceutical GMP, and GLP is a plus. 【Minimum Qualifications】 - Graduates with Bachelor's, or Master's degree in chemistry, biochemistry, molecular biology, life sciences, or biotechnology-related disciplines; candidates with industrial experience will be given additional consideration. 【Required application material】 • Curriculum vitae (CV) • Brief summary of research experience • References with contact information
積極徵才中
15 小時前聯絡過求職者
應徵
4/23
1.​執行及管理​新藥研發所需之動物實驗,探討藥物療效, 藥物動力學及藥物安全性等。 2.規劃並執行專案所需之免疫組織染色, 判讀並彙整結果,探討藥物作用機轉及適應症評估等。 3.依專案需求進行文獻搜尋、計畫評估、實驗設計及執行新藥研發專案所需之
3 天內聯絡過求職者
應徵
4/15
01. 原料、物料、設備、與委外發包詢比議價、採購、與請領作業。 02. 採購合約審閱、成本控管、訂單追蹤、交貨進度管控 03. 供應商資料建立、更新、變更通知、新舊供應商關係維持 04. 客訴處理、與採購/供應商問題處理 05. 原料、物料、臨床藥品與商業產品進出口報關稅務等行政作業 06. 主管交辦事項處理
積極徵才中
應徵
儲存清單
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