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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; 負責建立和管理研發質量管理體系；負責研發文件系統的管理；監督研發體系文件的執行情況，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; 負責研發工藝研究方案/報告、風險評估報告、批生產記錄、分析方法規程、分析方法開發方案/報告、穩定性研究方案/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; 負責研發原始記錄的審核、管理；研發實驗記錄規范性、完整性、數據真實性抽查，并形成記錄和報告；研發輔助記錄及時性、真實性、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; 負責開展質量管理的教育和培訓，定期更新和維護研發部門的培訓矩陣和培訓記錄； 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; 負責研制過程的質量管理，包括數據管理、偏差管理、變更管理、CAPA管理、風險控制與評估等質量要求； 6. Responsible for participating in quality audits related to the R&D department, and supervising the rectification and tracking of observations; 負責參與研發部門相關的質量審計，并督促缺陷項的整改追蹤； 7. Responsible for suppliers’ management; 負責研發供應商的管理； 8. Regularly organize and carry out R&D quality system review, responsible for continuous improvement of the quality system; 定期組織開展研發質量體系評審，負責質量體系的持續改進； 9. Complete other tasks arranged by superiors. 完成上級安排的其他工作。