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4/19 品質合規(資深)專員 Quality Compliance (Sr.) Specialist

  • 南投縣南投市
  • 2年以上
  • 大學

1. Review and enforce adherence to quality standards and agreements. 2. Manage non-conformance investigations and compliance. 3. Oversee GMP and regulatory compliance. 4. GMP Supplier Oversight: -Oversight the GMP Vender Audit Schedule. Ensuring Vendor and Auditor availability (internal/external/consultant) and confirming audit dates with both auditors and vendors. -reviewing supplier audit reports, ensuring they meet Lotus QA Standards and are compliant with Lotus SOPs. -Submitting observation reports to vendors, communicating response timelines and tracking them to ensure timely responses. Review of vendor audit responses and managing the review/editing cycle until responses are acceptable. Requesting documented evidence of closure when necessary and filing electronically and hard copy. 5. Manage quality assurance tasks including document control and investigations.

待遇面議 上市上櫃 外商公司 員工650人
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0~5人應徵

4/17 品管(草屯)

  • 南投縣草屯鎮
  • 1年以上
  • 高中

歡迎加入宏瑋醫材、宏瑋寵物 寵愛自己更是寵愛毛孩子 1.線上巡檢、進料檢驗及出貨檢驗。 2.依公司流程執行品保工作並進行品質改善。 3.檢驗報告產出、歸檔及ISO文件填寫。 4.客訴不良品處理與回覆。 5.分析統計資料及檢討。 6.主管交辦事項。 7.工作需要久站、久坐 8.動作敏捷、有效率、刻苦耐勞

月薪28,000~32,000元 員工150人
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0~5人應徵

4/15 文管管理師

  • 南投縣南投市
  • 2年以上
  • 專科

具文管經驗 1. 文管中心之文件管理(ISO文件系統化管理)。 2. ISO內外部稽核規劃、執行與異常改善追蹤。 3. 部門內工作支援。 4. 其他主管交辦事項。 文件管理師在企業內部扮演著重要的角色，負責將企業文件進行系統化整理，以確保文件能夠被快速找到，並且符合相關法規標準。隨著企業資訊化程度的提高，文件管理師的發展前景非常好，是一個非常值得投資的職業。 如果您是一位具有良好組織能力和時間管理能力的文件管理專家，並且擁有相關經驗和學歷，我們非常期待您的加入！

月薪30,000~35,000元 員工400人
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0~5人應徵

4/15 文管事務員

  • 南投縣南投市
  • 1年以上
  • 專科

1.熟品質系統文件管理(制訂/發行/修改/回收/建置/維護) 2.管控品質異常案件追蹤處理進度,品質分析統計資料分析整合。 3.協助稽核計畫或專案查核執行及代理認證稽核業務 4.規劃及執行內外部稽核異常改善追蹤與確認 5. 文件架構管理、定義簽核流程與權限。 6.品保內部管理報表統計 7.協助主管交辦事項

月薪28,000~38,000元 員工250人
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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

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4/14 技術服務(高級)專員 Technical Service (Advanced) Specialist

  • 南投縣南投市
  • 3年以上
  • 大學

1. Prepare and execute process validation activities which includes development trials, troubleshooting and monitoring the process validation batches. 2. Lead cleaning development and validation activities for new products, equipment change and quality improvement. This includes preparation of change controls, cleaning development and validation documents, risk assessment, cleaning records and other associated documents as required. 3. Comply with GMP and EHS regulations 4. Other responsibility request by line manager.

待遇面議 上市上櫃 外商公司 員工650人
0~5人應徵

4/14 製程品質保證(資深)專員 OQ (Sr.)Specialist

  • 南投縣南投市
  • 3年以上
  • 大學

1. Facilitate Lot disposition process, reviewing GMP docs and managing timelines. 2. Support day-to-day Quality Assurance - Operations. 3. Perform batch disposition activities within specified timelines. 4. Ensure timely review of batch records, SOPs, investigations, and adherence to quality agreements. 5. Set meaningful goals, metrics for groups, and manage performance. 6. Ensure safe, quality, and timely work. 7. Participate in continuous improvement projects, including QA systems and shopfloor processes. 8. Manage non-conformances investigation and compliance. 9. Ensure quality production and operation in accordance with schedule. 10. Quality Assurance management, covering documentation control, batch record review, investigations, production support, training, and compliance initiatives.

待遇面議 上市上櫃 外商公司 員工650人
0~5人應徵

4/14 (資深)研發品保專員 (Sr.) DQA Specialist

  • 南投縣南投市
  • 經歷不拘
  • 碩士

1. Responsible for ensuring “Good Laboratory Practices” required for analytical research and development , working knowledge of good development/manufacturing practices of formulation development will be added advantage. 2.Compliance review of API, Raw materials, Packaging materials documentation. 3.Compliance review of Stability data for submission batches documentation at regular intervals. 4.Ensure Document management archival procedure followed in place and support for compliance. 5.Active participate in Internal audit on all functional area pertaining to quality system and compliance and support regulatory audits readiness. 6.Ensure compliance of issuance/document control towards internal/external stake-holders. 7.Compliance review of raw data of Regulatory submission and Audit focused documents ensure error free documentation. 8.Conduct training-based training need identification, co-ordinate internal and external training programs and maintain training records of the team members. 9.Support document review for CTA documents. 10.Review and approve of New Equipment qualifications within R&D 11.Ensure Equipment/Instrument calibration and Qualification/Requalification programs adequacy as per the schedule. 12.Ensure Document compliance review at respective stages of Product development at kick off stage, Pilot Bio, Submission batches and filing stage. 13.Regular inspections on laboratories of development labs of both analytical and formulation 14.Any other responsibilities given Head of the Department /Management

待遇面議 上市上櫃 外商公司 員工650人
0~5人應徵

4/14 (資深)分析研究員 (Sr.) Analytical Researcher

  • 南投縣南投市
  • 經歷不拘
  • 大學

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 operations. Support relevant departments and vendors to complete projects on time, ensure the work and analysis comply with GMP and SOPs. 訓練、領導並監督日常實驗室操作中的初級分析師。協助相關部門和供應商按時完成專案，確保工作和分析符合GMP和SOPs。 7. Review documents, prepare the analytical study report and CMC documents 審查文件，準備分析研究報和CMC文件 8. Responsible for establishing, maintaining, and updating the specifications and test methods for in-process and finished products in the pre-approval phase. 負責核准前半成品和成品試驗相關之檢驗方法與規格之制定、維護與更新。 9. Support assigned responsibilities to maintain GMP compliance of the chemical laboratory, as applicable. 依據分配責任，維持化學實驗室運作皆符合GMP規範 10. Promptly complete work and tasks assigned by superior 及時完成上級下達的工作和任務。 11. Support for analytical method transfer to analytical control, QP sites, and other receiving laboratories. 協助將分析方法轉移到分析控制，QP所在地和其他接收實驗室。 12. Cooperating with PD & RA, complete and all lab tests. 配合PD及RA完成各項化驗項目。 13. Ensure analysis can be conducted with efficiency and completed on time 確保分析工作得以高效率及迅速之進行。 14. Managing and maintaining instrument calibrations, laboratory instrument logbooks, and SOPs. 各儀器設備SOP之制訂、管理、定期維護、校正如期完成。 15. Ensure lab work is conducted according to SOP and complies with EU, US, JP, and global cGMP regulations. 確保其實驗操作皆依照SOP進行，並符合歐美日地區及全球cGMP之規定。

待遇面議 上市上櫃 外商公司 員工650人
0~5人應徵
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