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1. Responsible for establishing and managing the R&D quality management system. Responsible for the management of the R&D file system. supervising the implementation of R&D system files, and forming records and reports; 負(fù)責(zé)建立和管理研發(fā)質(zhì)量管理體系；負(fù)責(zé)研發(fā)文件系統(tǒng)的管理；監(jiān)督研發(fā)體系文件的執(zhí)行情況，并形成記錄和報告； 2. Responsible for the review of process study protocols/reports, risk assessment report, batch production records, analytical method procedure, analytical method development protocols/ reports, stability study protocol/report and other documents for R&D; 負(fù)責(zé)研發(fā)工藝研究方案/報告、風(fēng)險評估報告、批生產(chǎn)記錄、分析方法規(guī)程、分析方法開發(fā)方案/報告、穩(wěn)定性研究方案/報告等文件的審核； 3. Responsible for the review and management of the R&D original records. Random checks on the standardization, completeness, and data authenticity of the R&D experiment records, and the formation of records and reports. Random checks on the timeliness, authenticity, and completeness of the R&D auxiliary records; 負(fù)責(zé)研發(fā)原始記錄的審核、管理；研發(fā)實(shí)驗(yàn)記錄規(guī)范性、完整性、數(shù)據(jù)真實(shí)性抽查，并形成記錄和報告；研發(fā)輔助記錄及時性、真實(shí)性、完整性抽查； 4. Responsible for carrying out quality management education and training, and regularly update and maintain the training matrix and training records of the R&D department; 負(fù)責(zé)開展質(zhì)量管理的教育和培訓(xùn)，定期更新和維護(hù)研發(fā)部門的培訓(xùn)矩陣和培訓(xùn)記錄； 5. Responsible for the quality management of the R&D, including quality requirements such as data management, deviation management, change management, CAPA management, risk control and evaluation; 負(fù)責(zé)研制過程的質(zhì)量管理，包括數(shù)據(jù)管理、偏差管理、變更管理、CAPA管理、風(fēng)險控制與評估等質(zhì)量要求； 6. Responsible for participating in quality audits related to the R&D department, and supervising the rectification and tracking of observations; 負(fù)責(zé)參與研發(fā)部門相關(guān)的質(zhì)量審計(jì)，并督促缺陷項(xiàng)的整改追蹤； 7. Responsible for suppliers’ management; 負(fù)責(zé)研發(fā)供應(yīng)商的管理； 8. Regularly organize and carry out R&D quality system review, responsible for continuous improvement of the quality system; 定期組織開展研發(fā)質(zhì)量體系評審，負(fù)責(zé)質(zhì)量體系的持續(xù)改進(jìn)； 9. Complete other tasks arranged by superiors. 完成上級安排的其他工作。