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    3/25 (Sr.) Associate, Quality Assurance (資深) 品保專員

    • 台北市南港區
    • 3年以上
    • 大學

    Essential Duties and Responsibilities: We are seeking a highly motivated and detail-oriented individual to join our Quality Assurance team. The ideal candidate has experiences in commercial drug quality activities and document management, with a strong commitment to maintaining the highest standards of quality and compliance in delivering pharmaceutical products. We are flexible to consider more senior roles depending on candidate qualifications. Quality Assurance Oversight: 1.. Conduct regular reviews of processes and documentation to ensure compliance with regulatory requirements and company standards. 2.. Perform batch record reviews and disposition activities in accordance with established procedures. 3.. Participate in internal and external audits, including preparation of audit documentation and response to audit findings. 4.. Collaborate with cross-functional teams to investigate deviations, non-conformances, recall handling, and customer complaints, and implement corrective and preventive actions as necessary. Document Management: 1.. Maintain and update quality documentation, including standard operating procedures (SOPs), batch records, specifications, and other quality-related documents. 2.. Ensure document control procedures are followed for the creation, approval, distribution, and archiving of quality documents. 3.. Support document change control processes, including reviewing and approving document revisions and ensuring timely implementation. Training and Compliance: 1.. Provide training to manufacturing personnel on quality procedures, GMP requirements, and document management processes. 2.. Ensure compliance with regulatory requirements, including FDA, EMA, and other applicable regulations and guidelines. 3.. Stay informed about current industry trends and regulatory developments related to quality assurance and document management. 4.. Identify opportunities for process improvements and efficiency enhancements within the Quality Assurance function. 5.. Participate in cross-functional teams to implement process improvements and drive a culture of continuous improvement throughout the organization.

    待遇面議 員工120人 距捷運南港軟體園區站約450公尺
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    0~5人應徵

    3/25 Associate Scientist/Scientist (Process Transfer) 製程技轉副研究員/研究員

    • 台北市南港區
    • 3年以上
    • 碩士

    Essential Duties and Responsibilities: Responsible for supporting intercompany and intracompany technology transfer of clinical trials and commercial product manufacturing processes technology. Support to the Process Development (PD) and Research development (RD) group as well as to the batch scale-up, clinical manufacturing in Pilot Plant, External Contract Manufacturing Organizations (CMO) and package and label activities to provide drug product for use in global clinical trials and commercial activities. We are flexible to consider more junior or senior roles depending on candidate qualifications. 1.. Work on technology transfer activities for clinical/validation and commercial products into commercial manufacturing facility. 負責將臨床和商業產品技術轉移至委外製造與生產單位。 2.. Work in conjunction with project teams to develop and gain agreement on milestone. 與專案團隊合作，制定里程碑已順利達成計畫目標。 3.. Work with external and internal organizational resources to achieve the requirements of the project plan. 整合外部夥伴和內部團隊資源，實現專案計畫的要求。 4.. Support of technology transfer activities about document review and approval, knowledge transfer, process support to ensure that all relevant information and materials are successfully communicated and applied during manufacturing in accordance with agreed upon timeline. 支援技術轉移活動，包括文件審查和批准、知識轉移、流程運作，以確保所有相關資訊和材料在生產過程中按照專案計畫時程成功傳達和應用。 5.. Cultivate relationships with external business partners and internal stakeholder groups, including (but not limited to) manufacturing, engineering, automation, technical development, quality, materials, site planning, technical operations, asset leaders, and supply chain planning. 培養與外部業務合作夥伴和內部利益相關群體的關係，包括（但不限於）製造、製程、自動化、技術開發、品質、材料、現場規劃、技術運營、資產領導和供應鏈規劃。

    待遇面議 員工120人 距捷運南港軟體園區站約450公尺
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    6~10人應徵

    3/25 Associate Scientist/Scientist, Bio-analytical 生物樣品分析副研究員/研究員

    • 台北市南港區
    • 3年以上
    • 大學

    Essential Duties and Responsibilities: Perform a wide range of bio-analytical tasks. Responsible for designing, and conducting experiments, developing, and validating methods, analyzing and interpreting data, communicating research findings, collaborating with team members, and ensuring regulatory compliance for specific projects. We are flexible to consider more junior or senior roles depending on candidate qualifications. 1.. Responsible for bioanalytical sample pre-treatment, analysis, data processing and troubleshooting for in-house pre-clinical pharmacokinetic (PK), bio-distribution, in-vitro leakage and R&D studies. 負責臨床前藥物動力學（PK）、生物分佈、體外滲漏和研究的生物分析樣本進行前處理、數據分析和故障排除。 2.. Develop, qualify and validate LC-MS/MS methods in support of pre-clinical and clinical programs and assure compliance with regulatory guidelines. 透過LC-MS/MS 方法開發、鑑定和驗證 ，以支持臨床前和臨床項目，確保符合監管準則。 3.. Draft and review protocol/methods/reports/SOP when required. 必要時進行審查協議/方法/報告/SOP。 4.. Conducting instrument performance qualification and generating relevant document. 進行儀器性能鑑定並制定產生相關文件。 5.. Manage daily administrative tasks associated with project timeline. 管理與專案時程相關的日常行政任務。 6.. Interact closely with cross-function groups to ensure that project milestones are met. 與跨職能團隊密切互動，確保專案里程碑地實踐。

    待遇面議 員工120人 距捷運南港軟體園區站約450公尺
    • 不想看到這個公司
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    0~5人應徵

    4/25 (Associate) Project/CMO Manager

    • 台北市南港區
    • 2年以上
    • 碩士

    Essential Duties and Responsibilities: The (Associate) Project and Contract Manufacturing Manager serves as the crucial liaison between the CMC division and CMOs, facilitating project coordination and communication among key stakeholders. This role collaborates closely with internal Project Leaders, CMC functional teams (Technical Transfer, Process and Analytical Development, and QA), and CMO/Partners to realize corporate objectives. The primary focus is on supporting projects across various phases at CMOs, encompassing technical transfer, clinical trial material supply, registration activities, and eventual commercial supply, while overseeing schedules and budgets. We are flexible to consider more junior or senior roles depending on candidate qualifications. 1.. Developing and drive timeline from technology transfer to GMP batch manufacturing for clinical supply, registration use and commercial supply. 2.. Manage external packaging, labeling, warehouse storage, and logistical activities on a monthly basis, tailored to project-based and commercial requirements. 3.. Facilitate communication between internal project team members and external CMOs through email, phone calls, meetings, or face-to-face interactions to address issues, milestone prerequisites, and project progress. 4.. Evaluate and recommend suitable CMOs for each project development phase through meticulous due diligence, assessment of investment requirements, and operational insights provided into agreements. 5.. Identify risks and devise mitigation strategies to ensure project timelines are met, collaborating closely with senior management. 6.. Coordinate project timelines, budgets, activities, and direction to align with corporate objectives. 7.. Collaborate with the business development team and external partners to map out commercial supply strategies. 8.. Negotiate contracts with CMOs (working in tandem with the Business Development team), prepare and monitor Purchase Orders, and track invoices according to project progress.

    待遇面議 員工120人 距捷運南港軟體園區站約440公尺
    • 不想看到這個公司
    • 不想看到這個產業
    0~5人應徵

    3/25 Associate Scientist/Scientist (Analytical Development) 分析開發副研究員/研究員

    • 台北市南港區
    • 3年以上
    • 大學

    Essential Duties and Responsibilities: Responsible for study design and study plan of the analytical development and related tasks. To perform a wide range of analytical tasks from new drug development phase, submission package and deficiency letter response. The work is critical to advancing our new drug development to commercial stage. We are flexible to consider more senior roles depending on candidate qualifications. 1.. Planning/ executing analytical method development/validation for raw material, drug substance, in-process control, intermediate and drug product. 規劃/執行原料、藥物、製程管制、中間體和藥物產品的分析方法開發/ 驗證。 2.. Technical reports preparing/ reviewing on research findings and report to supervisors or other scientists. 撰寫/審查研究報告，並向主管或其他科學家匯報。 3.. Planning/ performing experiments to test in new theories or existing theories. 針對新理論或現有理論進行規劃/執行/測試實驗。 4.. Designing/ conducting research into new products or methods of production to identify potential business opportunities. 設計/研究新產品或生產方法，以確定潛在的商業機會。 5.. Reviewing/ conducting analyses of data to support scientific research efforts. 審查/進行數據分析。 6.. Analytical method development/validation/technical transfer for liposomal drug product and drug substance. 脂質藥物產品和藥物的分析方法開發/驗證/技術轉移。 7.. Investigation when face analytical deviation that will influence the test results. 分析偏差調查。 8.. Analytical assessment/ evaluation report preparation. 撰寫分析評估報告。

    待遇面議 員工120人 距捷運南港軟體園區站約450公尺
    • 不想看到這個公司
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    6~10人應徵

    4/09 (Sr.) Associate, Legal (資深)法務專員

    • 台北市南港區
    • 5年以上
    • 大學

    Essential Duties and Responsibilities: Your primary focus will be serving as a valuable business enabler, overseeing contract reviews and providing legal advice to facilitate the company's rapid growth. We are flexible to consider more senior roles depending on candidate qualifications. 1.. Review, draft and negotiate related contracts with sales, procurement, NDA, distribution, maintenance, logistics, and a variety of other business transactions. 2.. Document and system management, including but not limited to internal control practice issue spotting, contract control and filing. 3.. Provide accurate and timely counsel in a variety of legal topics. 4.. Identify, research, develop, and analyze company policies, regulatory change, compliance requirements, and general legal and risk management issues. 5.. Conducting legal research and due diligence. 6.. Communicate and negotiate with external parties on all legal matters. 7.. Assist to prepare board agenda and general meeting. 8.. Assist stock transfer affairs and shareholder communication.

    待遇面議 員工120人 距捷運南港軟體園區站約450公尺
    • 不想看到這個公司
    • 不想看到這個產業
    0~5人應徵

    3/25 Associate Scientist/Scientist (Pharmaceutical Development) 製劑開發副研究員/研究員

    • 台北市南港區
    • 5年以上
    • 碩士

    Essential Duties and Responsibilities: Responsible for product formulation and process development/optimization. The scientists aim to optimize the performance of manufacturing systems by identifying and developing new formulation and manufacture processes, and implementing process controls to ensure the products are of high quality and produced in a way that can be replicated and scale-up. We are flexible to consider more junior or senior roles depending on candidate qualifications. 1.. Design, execute and report on formulation, process and scale-up studies for complex drug product development based on manufacturing and regulatory requirements. 根據生產和監管要求，設計、執行複雜藥品開發的配方和放大實驗研究。 2.. Propose and conducting experiments, critically evaluating data, and drawing appropriate conclusions to develop a forward plan of action. 針對實驗數據進行批判性地評估，以製定前瞻性行動計劃。 3.. Develop and maintain suitable project schedules, budgets and risk mitigation plans. 制定預算、專案時間表和風險評估計劃。 4.. Scientific research and technological trouble shooting on complex drug product formulation, process, material and equipment. 針對複雜藥品配方、製程、材料和設備進行科學研究和異常排除。 5.. Develop well control manufacturing process that can be transferred to external CMOs for large-scale production. 開發控制良好的生產製程，以便技士轉讓至外部 CMO 進行大規模量產。 6.. Communicate with internal stakeholders and external business partners via email, phone calls, meetings, or in person to discuss requirements, findings, methods, and progress on projects. 針對專案的需求、方法和進展，透過任意型式，包括（但不限於）電子郵件、電話、會議或面談與內部利害關係人和外部業務夥伴溝通。 7.. Lead junior scientists on studies for drug product development. 帶領初級科學家進行藥物產品開發研究。

    待遇面議 員工120人 距捷運南港軟體園區站約450公尺
    • 不想看到這個公司
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    6~10人應徵

    4/23 研究員(PD)

    • 台北市南港區
    • 5年以上
    • 碩士

    1. Pharmaceutical manufacturing process development and scale up, process parameters investigation and optimization. 2. Process technology transfer to CMO as well as dedicate process subject matter expertise. 3. Conduct GLP/ GMP manufacture and process verification/ validation activities in CMO for drug product. 4. Create and review CMC documents as well as GLP/ GMP documents. 5. Technical support for CTD submission packages preparation 6. Contract CMO coordinator

    待遇面議 員工30人
    • 不想看到這個公司
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    0~5人應徵

    4/23 助理研究員(PD)

    • 台北市南港區
    • 1年以上
    • 碩士

    1. Pharmaceutical manufacturing process development and scale up, process parameters investigation and optimization. 2. Pharmaceutical equipment design, qualification and unit operation in pilot lab and contract manufacturer. 3. Process technology transfer to CMO as well as dedicate process subject matter expertise. 4. Conduct GLP/ GMP manufacture and process verification/ validation activities in CMO for drug product.

    待遇面議 員工30人
    • 不想看到這個公司
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    0~5人應徵

    4/23 副研究員(PD)

    • 台北市南港區
    • 3年以上
    • 碩士

    1. Pharmaceutical manufacturing process development and scale up, process parameters investigation and optimization. 2. Pharmaceutical equipment design, qualification and unit operation in pilot lab and contract manufacturer. 3. Process technology transfer to CMO as well as dedicate process subject matter expertise. 4. Conduct GLP/ GMP manufacture and process verification/ validation activities in CMO for drug product. 5. Create and review CMC documents as well as GLP/ GMP documents. 6. Contract CMO coordinator

    待遇面議 員工30人
    • 不想看到這個公司
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    0~5人應徵

    呃拍謝，搜尋結果好像很少

    可以嘗試調整條件、或看看你專屬的推薦工作

    推薦工作

    4/26 QA Manager

    • 台北市南港區
    • 10年以上
    • 大學

    This candidate will lead the quality function at Syncell Inc, ensuring compliance to all applicable quality, customer, and regulatory requirements. As a key member of the site leadership team, this individual will provide the strategic direction to top management and perform the necessary oversight to achieve establishment and full implementation of the site Quality Management System (QMS). Responsible for establishing, leading and managing the Quality Team to support site operational performance and meet business needs. QMS site representative, leader for all regulatory and customer audits/inspections and contact person for QMS compliance issues. Responsibility: • Establish and maintain the company’s quality system, provide quality expertise and guide Quality department to effectively meet or exceed goals and target. • Collaborate with the various functions to ensure the quality management system is comprehensive, incorporates standard processes, and is consistent with the strategic plan. • Collaborate with cross-functional teams to formulate product inspection plans and ensure compliance with quality standards. • Product Development responsibilities including design controls, risk management, document control and record management, and supplier management. • Manufacturing responsibilities including process controls, labeling, change control/management, and CAPA. • Responsible for monitoring and measurement including validations, calibrations, customer feedback and complaints, Post Market Surveillance, internal audits. • Hire and retain a diverse, highly qualified staff and provides ongoing performance feedback. Set goals which align to department plans and be responsible for the execution of goals through coaching and mentoring. • Ensure continuous improvement through the Practical Process Improvement (PPI) • Ensure corporate, regulatory, and division quality requirements are met. • Ensure customer expectations are met or exceeded. Qualifications: • Bachelor of Science Degree in – Life Sciences, Engineering or related science/engineering degree preferred. • 10+ years of professional quality experience – Site quality leadership experience preferred. • Understanding of the Life Sciences or IVD/Medical Devices industries and required compliance regulations for products and processes. • Solid understanding and experience with ISO 9001/ISO 13485 standards • Experience in MDSAP, IVD/IVDR, 510K and GxP requirements is a plus. • Deep knowledge and experience implementing the following: Design and Process FMEA’s (Failure Mode Effects Analysis), CAPA (Corrective and Preventive Actions) process, Design Transfer, V&V, Complaints Handling process, Change Control/Management process, Post Market Surveillance Other Skills • Effective as a valued team member and colleague with leaders at all levels • Experience working and providing customer support, investigations, and relationship management. • Confirmed communication and internal/external customer management skills. • Experience supporting change management efforts. • Confirmed people leadership skills to build out the successful team. • Demonstrates personal awareness and desire for continual learning and personal development. • Hands-on and productive - Normally receives little instruction on day-to-day work, general instructions on new assignments. • Must possess the presentation skills and integrity to project a professional image, both internally and externally • Strong interpersonal, verbal and written communications skills are crucial.

    月薪70,000~100,000元 員工40人
    6~10人應徵

    4/25 品質管理副理 QA Assistant Manager

    • 台北市內湖區
    • 3年以上
    • 大學

    此職務主要協助品保團隊進行品質系統的整合、導入、維護與持續改善工作，以確保公司服務、產品和流程符合相關法令與法規要求(例如ISO 13485, CAP, LDTS, ISO 27001, ISO 27701等)。歡迎具有CAP或GLP實驗室經驗或ISO 13485醫療器材品質管理經驗的求職者投遞。 主要職責如下： 1. 協助公司品質系統的整合、推行與維護之作業，例如矯正預防、變更管制、設計管制、供應商管理、抱怨處理等品質活動，並協助品質系統的持續改善活動以符合相關法令法規與客戶之要求。 2. 並對實驗室與製造產線出現的品質事件進行跟蹤與處理。 3. 參與品質相關文件的撰寫、審閱以及核准，與跨部門單位合作進行品質相關專案的推進並提供品質或法令法規相關意見。 4. 參與產品設計與開發相關活動，與跨部門專案團隊合作確保產品之設計開發或相關生產製造流程符合內部規範以及法令法規與客戶之要求。 5. 負責或協助公司內外部稽核活動，包括主管機關、驗證單位、國內外客戶之定期或不定期稽核，並進行缺失改善回覆與追蹤。 6. 負責、積極主動且善於溝通，並能進行跨部門溝通協助解決問題。 7. 其他主管交辦事項。

    待遇面議 員工200人
    6~10人應徵
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