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Job Responsibilities/崗位職責 1.Participate in the construction and maintenance of the R&D system, participate in the management of the R&D system. Assist the implementation of the R&D quality system. 參與研發(fā)體系的建設及維護；參與研發(fā)系統(tǒng)的管理；協(xié)助研發(fā)質(zhì)量體系的實施； 2.Report any finding in R&D lab management to CTO weekly, and plan the improvement as needed. 每周向CTO匯報研發(fā)實驗室管理工作中發(fā)現(xiàn)的問題，并提出整改措施； 3.Responsible for the management of the daily activities of R&D site, supervise the R&D site and its improvement, including on-site records, equipment management, daily maintenance, personnel operation, etc. 負責日常研制現(xiàn)場日?；顒拥墓芾?，對研發(fā)現(xiàn)場進行督察并監(jiān)督整改，包括現(xiàn)場記錄、設備管理、日常維護、人員操作等； 4.Responsible for the distribution and review of R&D original records. Responsible for R&D experimental notebook standardization, Audit the completeness, authenticity of all the data, and write the audit records and reports. Review the timeliness, authenticity, completeness of auxiliary records. 負責研發(fā)原始記錄的分發(fā)和審核管理；研發(fā)實驗記錄本規(guī)范性、完整性、數(shù)據(jù)真實性抽查，并形成記錄和報告；輔助記錄及時性、真實性、完整性抽查； 5.Responsible for the review process instruction, batch production records, quality standards, verification plans/reports, testing procedures, testing records/reports and other documents for R&D. 負責研發(fā)用工藝規(guī)程草案、部分批生產(chǎn)記錄、質(zhì)量標準、確認方案/報告、檢驗操作規(guī)程、檢驗記錄/報告等文件的審核； 6.Responsible for R&D material management, including purchasing, requisitioning, inventory,etc. 負責研發(fā)物料管理，包括采購、領用、庫存盤點等； 7.Training of R&D staff related to laboratory management. 對研發(fā)人員進行實驗室管理相關的培訓工作； 8.Complete other tasks arranged by superiors. 完成上級安排的其他工作。 Job Requirements/崗位要求 1.Bachelor degree, science subject is preferred. 本科學歷，科學學科優(yōu)先考慮； 2.1-5 years of lab management industry experience, pharmaceutical or medical device experience is preferred. Those with quality management experience in biopharmaceutical are better. 1-5年實驗室管理行業(yè)經(jīng)驗，制藥或醫(yī)療器械經(jīng)驗優(yōu)先考慮。具備生物制藥質(zhì)量管理經(jīng)驗者更好； 3.Self-motivated, capable of handling independently, organizing and arranging multiple tasks, and able to perform under pressure and in line with the timeline. 有上進心，有能力獨立處理，組織和善于安排多項任務，并能在壓力下執(zhí)行并符合時間線； 4.In-depth knowledge of GXPS and related guidelines and regulatory requirements. 熟悉GXPS和相關指南、法規(guī)要求； 5.Good oral and written communication skills in English and Mandarin, able to communicate effectively with other functional departments. 良好的英語和普通話口語和書寫交流能力，能有效與其他職能部門溝通。