「藥品製劑處-藥品製劑組-資深專案經理」的相似工作
財團法人醫藥工業技術發展中心共139筆
滿好集團_滿好貿易股份有限公司汽機車及其零配件用品／批發業
1. 店務管理規劃
2. 教育訓練規劃
3. 促案規劃
4. 數據分析
5. 營運建議
6. 其他細節於面談時說明
-跨部門溝通
-專案執行
-抗壓性/理解力強
-主動積極
-強大學習欲
10/21
財團法人醫藥工業技術發展中心其他專業／科學及技術業
1.負責新市場開拓與當地市場法規等資訊蒐集。
2.橋接國內藥廠與國外合作對象之溝通聯繫。
3.市場分析與市場報告。
4.各項國際活動(參展、參訪團等)之規劃與執行。
10/21
健喬信元醫藥生技股份有限公司藥品製造業
1. Responsibilities and Job Requirements:
*Responsible for reviewing Finished NDA and ANDA CMC documents to ensure compliance with international and regional regulatory standards.
*Coordinate with internal teams to ensure product compliance and registration progress.
*Provide technical and regulatory expertise, assisting in resolving product development and regulatory issues.
*Familiar with regulatory requirements in various countries to ensure submitted documents adhere to local regulations.
*Participate in cross-functional collaboration during the review process to ensure effective project execution.
*Manage the team, provide guidance and professional training, ensuring optimal team performance.
2. Qualifications and Skills Required:
*Bachelor's degree or above in Pharmacy, Chemistry, or a related field.
*Minimum of 5 years of experience in drug review.
*Familiarity with international drug regulatory requirements, including ICH, FDA, EMA, etc.
*Excellent communication and leadership skills, with the ability to effectively manage teams and coordinate cooperation.
*Strong problem-solving and decision-making abilities, capable of addressing complex regulatory challenges.
*Fluent spoken and written English communication skills.
1. 職責與職位要求：
*負責審查NDA/ ANDA製劑相關文件，確保其符合國際和地區監管標準
*與內部團隊協調，確保產品的合規性和註冊進度
*提供技術和法規方面的專業建議，協助解決產品開發和監管問題
*熟悉各國監管要求，確保提交的文件遵守各地的法規
*參與審查過程中的跨部門協作，確保項目的有效執行
*管理團隊，提供指導和專業培訓，確保成員發揮最佳水平
2. 資格與技能要求：
*擁有藥學、化學或相關領域的學士或以上學位
*至少有5年以上的藥品審查經驗
*熟悉國際藥品監管要求，包括ICH、FDA、EMA等
*優秀的溝通和領導能力，能夠有效管理團隊和協調合作
*強大的問題解決和決策能力，能夠應對複雜的監管挑戰
*流利的英語口語和書面表達能力
10/20
心悅生醫股份有限公司生化科技研發業
1. A M.S. or Ph.D. degree in Chemistry or Pharmacy with no less than two years of industry
R&D experiences.
2. Strong background in analytical/medicinal/or organic chemistry.
3. Well-experienced in analytical method development and validation.
4. Hands-on experience in the development and characterization of intermediate of active
pharmaceutical ingredient , formulation development and/or PK study analysis.
5. Excellent communication skills and good team spirit.
6.Looking for who is willing to take the challenge to be a pioneer combination chemist for
novel drug discovery of CNS disorder.
10/21
財團法人醫藥工業技術發展中心其他專業／科學及技術業
1.藥品查驗登記申辦輔導，含檢核申請文件、臨床試驗法規遵循、應對查驗、缺件補件及後續查詢事宜。
2.執行政府專案法規研究(國內外)，及負責專案計畫管考。
3.追蹤並分析國內外藥品法規最新動態，並提供相關法規諮詢。
10/21
10/02
祥翊製藥股份有限公司藥品製造業
1. HPLC、GC分析方法開發
2. 安定性試驗設計及報告撰寫
3. 撰寫品質文件
4. 執行ISO與GMP相關業務
5. 協助原料、半成品、成品檢驗業務
6. 協助實驗室校正與維護作業
10/23
松瑞製藥股份有限公司生化科技研發業
1.製劑產品可行性評估與技術轉移
2.規劃並管理開發時程與成本
3.協調委外製劑開發/生產(CDMO/CMO)
4.跨部門溝通(品保、法規等)，確保專案順利推進
5.其他專案事項
10/16
諾佛葛生技顧問股份有限公司其他醫療保健服務業
Please do submit English resume to our company website.
https://fa-euzi-saasfaprod1.fa.ocs.oraclecloud.com:443/hcmUI/CandidateExperience/en/job/1488?utm_medium=jobboard
General Responsibilities:
Manage staff in accordance with organization's policies and applicable regulations, including without limitation: planning, assigning, and directing work; managing performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems; acting as a coach and mentor for subordinates as they develop in their role.
Participate in the selection and onboarding process for new staff by conducting candidate review and participating in the interviewing process. Conduct onboarding training for new staff in conjunction with Human Resources and Learning and Development training programs.
Ensure that staff have the proper materials, systems access and training to complete job responsibilities. Provide oversight for the execution of the training plan, SOP review and mentored training experiences, as applicable.
Maintain lab daily operation.
Ensure the quality and timely of lab deliverable.
Perform the tasks assigned by line manager.
Refer to additional GLP/GCP Regulation Required Responsibilities while involved in GLP organization.
As the member of test facility/site management.
Delegated /assigned as the system owner for computerized system, do the corresponding work for system, such as validation test, periodic review, report, etc.
GLP/GCP Regulations Required Responsibilities (if needed):
Lab Manager
Maintain an internal responsibility chart which identifies the individual(s) within a test facility who fulfil the responsibilities of management as defined by the Principles of Good Laboratory Practice.
Ensure that a sufficient number of qualified personnel, appropriate facilities, equipment, and materials are available for the timely and proper conduct of the study.
Ensure the maintenance of a record of the qualifications, training, experience and job description for each professional and technical individual.
Ensure that personnel clearly understand the functions they are to perform and, where necessary, provide training for these functions.
Ensure that for each study an individual with the appropriate qualifications, training, and experience is designated by the management as the Study Director before the study is initiated. Replacement of a Study Director should be done according to established procedures, and should be documented.
Ensure, in the event of a multi-site study, that, if needed, a Principal Investigator is designated, who is appropriately trained, qualified and experienced to supervise the delegated phase(s) of the study. Replacement of a Principal Investigator should be done according to established procedures, and should be documented.
Ensure documented approval of the study plan by the Study Director.
Ensure that the Study Director has made the approved study plan available to the Quality Assurance personnel.
Ensure the maintenance of a master schedule.
Ensure that test facility supplies meet requirements appropriate to their use in a study.
Ensure for a multi-site study that clear lines of communication exist between the Study Director, Principal Investigator(s), the Quality Assurance Programme(s) and study personnel.
Ensure that test and reference items are appropriately characterized.
Ensure that appropriate and technically valid Standard Operating Procedures are established and followed, and approve all original and revised Standard Operating Procedures.
If necessary, function as Study Director for specific study, in this case, he/she must not have the responsibility of test facility/site management role in the study.
10/20
戴壟生技股份有限公司生化科技研發業
協助製程部執行日常生產作業、依據 SOP 完成批次紀錄（Batch Record）與領料、操作生產設備並配合 QC/QA 做樣品抽檢與異常回報，確保產品品質與生產合規。
• 按照 SOP/工作指示準備並稱量原料，進行配料與樣品取樣，維持領料/使用紀錄完整。
• 協助操作與監控生產設備（如過濾、乾燥、粉碎、包裝等基礎流程）；協助設備清潔（CIP/SOP）與簡單保養。
• 完成生產批次紀錄（BPR）、生產日誌與其他文件化作業，確保紀錄可追溯且符合法規要求。
• 配合 QC 取樣、送檢，並協助處理生產偏差（Deviation）與 CAPA 基礎資料蒐集。
• 遵守潔淨室、換裝（gowning）與人/物流流向規範，確保生產區域潔淨與防交叉污染（GMP 人員/物料分流）。
• 協助日常庫存盤點、包材準備與成品入庫／出貨作業（依分工）。
• 接受製程/品質/安全訓練，並在主管指示下完成相關紀錄與內部稽核配合。
• 具有食品或生技製程經驗者優先。
• 良好中文書寫與口語表達能力；可讀英文 SOP 與基本操作手冊優先。
• 良好團隊合作、守時與責任感；抗壓性佳
10/21
山酮新藥開發股份有限公司生化科技研發業
經常性事務
1. 優化與開發劑型與成品製程。
2. 落實藥材、原料藥及成品之品質管理分析與文件審閱。
3. 管理與追蹤成品試製生產及確保交付品質。
4. 擬訂研究計畫協助實驗、研究資料蒐集、數據統計分析、實驗及資料歸納整理。
5. 確認與更新成品 CMC法規及規格。
6. 管理與追蹤活性檢驗/劑型之委外研發、製造之委外試驗及 CMC 相關委外檢驗等專案。
7. 執行 ERP行政採購事宜。
8. 執行主管交辦其他事項。
非經常性事務
1. 協助盤點與管理藥品及原料庫存，確保庫存量(成品、藥品及原料)。
2. 維護實驗室儀器與器材，年度驗證執行。
3. 毒化物登記申報。
4. 編列各專案預算與規劃執行。
5. 管理供應商，執行新增、變更之作業。
6. 執行與協助其他部門支援事項。
10/22
健喬信元醫藥生技股份有限公司藥品製造業
We are seeking a highly motivated and innovative R&D Scientist to join our pharmaceutical development team. The successful candidate will contribute to the design, formulation, development, and optimization of drug products, with a focus on quality, scalability, and regulatory compliance. This role offers the opportunity to work in a collaborative environment with cross-functional teams including Regulatory, Analytical/QC, Quality, Manufacturing, and Business Development.
1.Conduct research and development of new drug formulations for Global Regulated markets (Nasal – Solution, Spray, DPI, pMDI etc.)
2.Follow Quality by Design to plan & execute lab-scale experiments, stability studies, and process development activities including DOE.
3.Responsible for managing monographs, validated excel sheets, approved reports (paper and electronic), notebooks and document archival.
4.Develop & optimize manufacturing processes in compliance with cGMP requirements.
5.Participate in Technology transfer to manufacture pilot, scale up, submission & commercial batches.
6.Prepare technical documents, as per cGMP & ICH for execution and manufacturing including batch records, protocols and reports.
7.Prepare regulatory submission documents as pe ICH including chemistry manufacturing & controls (CMC), product development report, overall quality summary (OQS) etc.
8.Execute CCR, deviation investigation, CAPA, LIR, SOP preparation, internal and support GMP inspection.
9.Stay updated with scientific & global regulatory advancements and ensure knowledge sharing with co-workers.
10.Collaborate with cross-functional teams on project timelines and deliverables
10/16
博惠生技股份有限公司生化科技研發業
1. 負責藥品研究開發及相關作業執行，有法規單位送件經驗者佳。
2. 內部跨部門工作協調及外部廠商溝通業務，有CRO、CMO經驗佳。
3. 具獨立完成問題分析及解決能力。
4. 具藥廠研發經驗或新藥開發經驗。
5. 主管交辦事項。
6. 重視團隊合作，具良好溝通協調能力。
10/23
財團法人醫藥品查驗中心其他醫療保健服務業
1.新藥查驗登記申請案之技術性資料審查，包含審查新藥之藥動學資料、臨床試驗計畫書、銜接性試驗評估、含藥醫材及上市後變更資料。
2.學名藥查驗登記申請案之技術性資料審查，包含審查臨床試驗計畫書、生體可用率/生體相等性試驗報告書、體外比對試驗資料及上市後變更資料。
3.藥品研發法規諮詢輔導相關事務
4.研擬法規草案、基準及指導原則。
5.其他交辦事項。
請至本中心網站【加入CDE】專區了解更多職缺訊息： https://www.cde.org.tw/joincde/1409/1999/13531/jobList
10/20
臺灣生物醫藥製造股份有限公司藥品製造業
Principle Roles & Responsibilities
1.物理及化學分析設備的規格書撰寫,採購,驗證及操作文件撰寫
2.物理及化學分析實驗室管理及相關管理SOP撰寫
3.原料/生產產品檢驗相關分析方法的技轉,確效,及操作SOP撰寫及執行
4.參與物理及化學分析實驗室操作人員在職訓練
5.制定並執行穩定性測試計劃，以及分析方法的驗證與確效。
6.評估穩定性趨勢與分析數據。
7.負責物理和化學分析相關設備的校準與預防性維護活動。
8.審核所有物理和化學測試的檢測結果。
9.解決原料、成品、生產過程研究及驗證中的物理與化學測試問題，進行故障排除和解決。
10.向實驗室主管或代理人報告設備故障及安排維修
11.負責實驗室試劑和消耗品的充足庫存，透過監控再訂購水平並及時通知。
12.負責準確的記錄分析數據與結果於記錄本、產品規格與品質保證報告，以及實驗室分析表單，並以趨勢監測的角度記錄結果。
13.負責調查物理與化學實驗室的超出規格（OOS）與偏差事件。
14.以持續改進的態度執行工作，以達成既定的關鍵績效指標（KPI）。
15.完成主管或公司指派的其他任務。
Secondary Responsibilities
1.協助準備分析所需的試劑，並按照標準書面方法，在規定的時間間隔內對容量分析溶液進行標定。
2.參與產品、原料、包裝材料及穩定性樣品物理與化學相關分析。
3.協助分析人員執行實驗室設備的校準與預防性維護活動。
4.參與分析方法技轉程序。
5.負責確認內部開發的分析試劑的有效期限，並確認在其容器或文件上有標註到期日。
6.根據標準安全規範處理和處置危險材料，如砷、氰化物和濃酸。
7.按照標準預定程序，記錄受管制的有毒化學品的使用與處置情況。
10/19
山酮新藥開發股份有限公司生化科技研發業
1. 管理與追蹤臨床受託研究機構(CRO/SMO…)公司、醫療機構之專案。
2. 管理與追蹤臨床專案執行品質、文件整理。
3. 落實臨床專案相關文件(計劃書、GCP…等)之設計、審閱與歸檔。
4. 協調臨床試驗相關事宜，加速臨床試驗進程。
5. 協助及配合臨床試驗監測與稽核。
6. 執行主管交辦其他事項。
10/17
訊聯細胞智藥股份有限公司其他醫療保健服務業
醫藥/醫療器材/化妝品領域都是我們正在找尋的人才喔 ~
1.負責彙總、解讀藥物註冊法規、技術要求(包含但不限於TFDA、FDA法規、ICH指南)，並為公司研發提供合規指導和風險管理；
2.準備原始IND、修改和補充，包括與其他部門對接以獲得必要的組件和草稿報告和敘述組件
3.了解藥品的生命週期和基本的GMP工作流程
4.積極參與監管報送流程及參與產品開發週期的風險評估
5.跟進公司在研專案分配與協調，跟進註冊專案進度，及時發現和處理註冊專案進程中的問題，確保完成註冊任務;
6.協調和處理註冊評審過程中的相關問題；
7.及時掌握藥品註冊政策的變化情況，對研發人員進行培訓和管理。
1. To prepare timely original IND, amendments, and supplements, including interfacing with other departments to obtain the necessary components and drafts reports and narrative components
2. Understanding of the lifecycle of drug products and basic GMP workflow
3. Actively involved in the regulatory submission process
4. Involve in the risk assessment during product development cycle
10/16
聯亞藥業股份有限公司藥品製造業
1. 熟悉國外法規機關(主要為US FDA)之藥證申請流程與相關法規
2. 以英文撰寫國外查驗登記CTD文件
3. 需有成功取得國外(US or EMA)針劑藥證之經驗
4. 維護國外之上市後藥證
5. 有關國外藥證之事務溝通、協調、提供意見與資料
10/21
保盛藥業股份有限公司藥品製造業
主要職務:
1. New project evaluation, perform literature study
2. Pharmacology and PK/PD data interpretation
3. Assist nonclinical & clinical CRO management
4. Project management for new drug development
詳細職務內容:
1. In-depth study on marketed drugs and their target indications, consider MOA, PK/PD profile, formulation design, brainstorming for new project ideas.
2. Various literature search and information gathering per supervisor’s request
3. Assist in nonclinical study design.
4. Assist in CRO contracting and follow up study execution.
5. Data processing & provide scientific interpretation.
6. Serve as PM role in various projects, taking meeting minutes, tracking development progress
10/23
財團法人醫藥品查驗中心其他醫療保健服務業
1.醫療器材查驗登記案件審查
2.醫療器材臨床試驗案審查
3.醫療器材研發過程諮詢輔導相關業務
4.其他交辦事項
請至本中心網站【加入CDE】專區了解更多職缺訊息： https://www.cde.org.tw/joincde/1409/1999/13531/jobList