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General Mission職責概述 · Operate QC analysis in compliance with analytical methods, Assuring quality, Good Documentation Practices, cGMP, safety health and environmental standards are met. 按照分析方法操作理化實驗，確保符合質(zhì)量、文件記錄和GMP以及環(huán)境/安全/健康的要求。 · Constitutes standard operating procedures, analytical methods and perform the equipment qualification. 制定標準操作規(guī)程和分析檢驗方法，并執(zhí)行設(shè)備的確認。 Activities具體職責 · Analysis of raw materials, semi-finished, finished products, validation sample and project sample according to the analytical methods and pharmacopoeia requirements. 按照分析方法及藥典的要求進行原輔料，半成品，成品，驗證樣品和項目樣品的檢驗。 · Executing analytical testing in a timely manner, ensuring adherence to the committed scheduled plans. 及時執(zhí)行分析測試，確保遵守承諾的計劃。 · Ensuring that he/she is trained and qualified to the assigned analytical testing that requires to be qualified. 確保他/她接受過培訓并具備指定分析測試所需的資格。 · Performing the QC data review of executed tests by other analysts in a timely manner, ensuring adherence to the committed schedules plans. 及時對其他分析員執(zhí)行的測試進行質(zhì)量控制數(shù)據(jù)審查，確保遵守承諾的時間表計劃。 · Informing his/her manager of any quality or HSE event (deviations, OOx,…) in a timely manner to ensure investigation and impact assessment are performed appropriately. 及時向其經(jīng)理通報任何質(zhì)量或 HSE 事件（偏差、 OOx等），以確保適當進行調(diào)查和影響評估。 · Participating actively to any investigation, where he/she is involved, to ensure investigations and impact assessment are performed appropriately. 積極參與其所涉及的任何調(diào)查，以確保調(diào)查和影響評估得到適當進行。 · Executing assigned CAPAs related to remediation plans, continuous improvements. 執(zhí)行與補救計劃相關(guān)的指定 CAPA并持續(xù)改進。 · Ensuring that his/her lab/facilities, lab instruments, are kept in a quality and safety status to ensure that they can be used appropriately. 確保他/她的實驗室/設(shè)施、實驗室儀器保持質(zhì)量和安全狀態(tài)，以確保它們能夠得到適當使用。 · Implements the maintenance/validation/verification of laboratory equipment in compliance with the established schedules and maintain accurate records and documentation. 按計劃對QC 實驗室儀器進行維護、校準并準確記錄和存檔。 · Maintain the reference standards as well as the relevant documentation and record. Maintain the reagents and their records. 負責對照品的管理及記錄。負責試劑的管理及記錄。 · Support the QC Supervisor with writing draft procedures, draft qualification protocols of the analytical instruments and the analytical methods. Perform the qualification work. 協(xié)助QC主管編寫標準操作規(guī)程、儀器確認草案及分析方法驗證方案。進行確認工作。 · Implement stability study according SOP and finish stability report on time 負責管理執(zhí)行穩(wěn)定性考核工作，并及時完成穩(wěn)定性考核報告。 · To be the backup of the other analysts in case of absent. 其它分析員缺席時作為替補。 · Be responsible for HSE in his/her position and job. 對本崗位的職業(yè)健康安全環(huán)境工作負責。 · Other works assigned by the leader. 上級安排的其他工作。 About you 任職資格: List here ideally the must-haves criteria to be successful on the role. 請列出勝任該職位所必須具備的條件。 · Experience: More than two years working experience in QC. Be familiar with chemical analysis and have experience in analytical method and instrumental validation,including knowledge of Good Manufacturing Practices (GMP) and regulatory requirements. 工作經(jīng)驗: 兩年以上QC工作經(jīng)驗，熟悉QC 理化分析, 有分析方法和儀器驗證工作經(jīng)驗，包括良好生產(chǎn)規(guī)范 (GMP) 和監(jiān)管要求的知識。 · Soft skill: Familiar to cGMP and regulation, Familiar to office software, Good communication and transversally cooperation, team leading 通用技能：熟悉現(xiàn)行GMP和法規(guī)，熟練應用辦公電腦軟件，良好的溝通協(xié)調(diào)能力，團隊領(lǐng)導力。 · Technical skill: 專業(yè)技能: · Familiar to CHP, Chinese & EU & United state GMP, ICH regulation。 熟悉中國藥典，中歐美GMP，ICH等法規(guī)。 · Ability to analyze complex data and laboratory results to make informed decisions and identify areas for improvement. 能夠分析復雜的數(shù)據(jù)和實驗室結(jié)果以做出明智的決策并找出需要改進的領(lǐng)域。 · Keen attention to detail to ensure accuracy in testing, reporting, and compliance with regulatory requirements. 高度重視細節(jié)，以確保測試和報告的準確性并符合監(jiān)管要求。 · Proficiency in identifying issues and implementing effective solutions to resolve quality control problems. 能夠熟練地發(fā)現(xiàn)問題并實施有效的解決方案來解決質(zhì)量控制問題。 · Education: bachelor’s degree above, Pharmacy or related field 教育背景: 本科學位以上，藥學或相關(guān)專業(yè)。 Languages: Good at English reading, writing，be able to discuss the topics of quality and testing in English. 語言要求: 良好的英語讀、寫能力，可以用英語探討質(zhì)量和檢驗相關(guān)的話題