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1. Participate in the compliance review of Production Department (DP) related GMP documents and records, including Master Production Instruction, Batch Record as well as related management and operation SOPs, etc. 參與生產部門(制劑)相關GMP文件和記錄的合規(guī)性審核，包括工藝規(guī)程、批記錄、和相關管理及操作類SOP等； 3. Participate in the handling of Production department (DP) related quality events, including deviation, change control, CAPA, etc. 參與生產部門(制劑)相關質量事件的處理，包括偏差、變更、糾正與預防措施等； 4. Participate in the review of validation (or qualification) and re-validation (or re-qualification) plans and reports for equipment related to the production department (DP). 參與生產部門（制劑）相關設備驗證（或確認）和再驗證（或確認）方案和報告的QA審核； 5. Oversee GMP compliance of the operation and site management of Production department (DP). 監(jiān)督生產（制劑）部門的操作和現場管理的GMP合規(guī)性； 6. Oversee the data integrity compliance of related area. 監(jiān)督相關區(qū)域數據完整性的合規(guī)性； 7. Participate in AQL as required. 根據內部工作分工需要參與AQL。