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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. 參與研發體系的建設及維護；參與研發系統的管理；協助研發質量體系的實施； 2.Report any finding in R&D lab management to CTO weekly, and plan the improvement as needed. 每周向CTO匯報研發實驗室管理工作中發現的問題，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. 負責日常研制現場日常活動的管理，對研發現場進行督察并監督整改，包括現場記錄、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. 負責研發原始記錄的分發和審核管理；研發實驗記錄本規范性、完整性、數據真實性抽查，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. 負責研發用工藝規程草案、部分批生產記錄、質量標準、確認方案/報告、檢驗操作規程、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年實驗室管理行業經驗，制藥或醫療器械經驗優先考慮。具備生物制藥質量管理經驗者更好； 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。