職位描述
Responsibilities:
Implement GMP compliance against global GMP standards and China GMP requirement
根據總部和中國GMP要求，完善GPM的實施工作
· By assisting P&C lab. Manager to conduct GMP Self- Inspection, and follow-up the implementation action to maintain the global level of GMP compliance.
協助理化實驗室經理實施GMP自查，跟蹤改進實施計劃，維護全球性的GMP實施水平
· By maintaining the quality system and documentation system to ensure quality system operations in QC meets the regulatory.
通過維護質量體系和文件系統，確保質量控制部的質量運作體系符合法規要求
Effectuate management of sample distribution and analytical process inspection to ensure timely releases of analytical report to support business need.
實施樣品分發和檢驗過程的管理職責，保證檢驗報告及時放行，以支持業務需要。
· By managing working schedule of relative section, to optimize utilization of human resources.
管理相關領域的工作計劃，優化人員使用效率
· By monitoring the analysis process to push the analytical report issued in reasonable lead time.
監控分析過程，督促下屬在合理的分析周期內簽發分析報告
· By monitoring the timely calibration and maintenance of instrument within working section, ensure keeping in good order.
監控工作領域內儀器的按時維護、校驗和保養狀況，以保證儀器設備的正常使用。
· By monitoring the timely logged, complement of reagents, vessel, reference standard substances, etc. in working section, and ensure sufficient supply.
監控工作領域內試劑、器皿、標準品等的登錄和補充狀況，以保證正常足量供應。
Tutor subordinators to fulfill analysis tasks.
指導下屬完成分析任務。
· By providing technical support to subordinators if necessary share knowledge and experience within working section.
需要時向下屬提供技術支持，分享工作領域內的知識和經驗。
Complete the assigned routine inspection of sample, issue the reliable analytical report in reasonable lead time.
完成分配的日常檢驗樣品，在合理的分析周期內簽發正確的分析報告。
· By master analytical methods within working section, comply with professional morality and etiquette to ensure reliability and integrity of the analytical data and keeping the excellent capacity of working suitability.
熟練掌握工作領域內的分析方法，遵守職業道德和操守，確保分析數據的可靠性和完整性，具備良好的工作適應能力。
· By rationalize time allocation, optimizing combination the samples in hand, to keeping the reasonable lead time.
通過工作時間的合理分配，優化待分析樣品的組合，保持合理的 分析周期。
· By form a good working habit to standardize experimental operations.
養成良好的工作習慣，規范實驗操作。
· By checking analysis result serious and careful to minimize mistakes and ensure accuracy and reliability of testing figures.
通過認真仔細地復核分析記錄，盡量減少差錯，保證數據的準確性和可靠性。
Implement the maintenance and calibration of assigned instruments
實施分管儀器的維護、校驗和保養工作。
· By accomplish the calibration and maintenance of assigned instruments, to ensure they are in good order to meet the analytical needs any time.
完成指定儀器的維護、校驗和保養工作，確保儀器設備隨時滿足分析需要。
· By keeping the relevant document to trace the calibration, maintenance history and any change of the instruments.
保管相應文件，以便追溯儀器的維護、校驗和保養歷史以及所有變更
· By keeping contact with instrument company to obtain the sufficient application technical support.
保持與儀器公司聯系，以及時獲得足夠的儀器應用的技術支持。
· By keeping contact with instrument company to obtain the repair service in time.
保持與儀器公司聯系，以及時獲得及時的維修服務
Implement the analysis method validation.
實施分析方法驗證
· By initiate the defined analysis method validation via planning, executing and reporting process.
通過計劃、實施和報告階段啟動指定的分析方法驗證工作。
· By organizing the resources to complete yearly method validation plan.
通過組織資源、完成年度方法驗證計劃。
Qualification:
Bachelor of Science Degree or above 理學士及以上學位
Pharmacy, Chemistry, Biochemistry and equivalent 藥學、化學、生物化學及相關學科
At least 4 years’ experience in Quality Control of major or joint venture Pharma Company.
至少4年在大型或合資制藥企業質量控制工作經驗
Language skills – English & Chinese 語言能力-英語及國語
