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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(chǎn)部門(制劑)相關(guān)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(guān)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(chǎn)部門(制劑)相關(guān)質(zhì)量事件的處理，包括偏差、變更、糾正與預(yù)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(chǎn)部門（制劑）相關(guān)設(shè)備驗(yàn)證（或確認(rèn)）和再驗(yàn)證（或確認(rèn)）方案和報(bào)告的QA審核； 5. Oversee GMP compliance of the operation and site management of Production department (DP). 監(jiān)督生產(chǎn)（制劑）部門的操作和現(xiàn)場管理的GMP合規(guī)性； 6. Oversee the data integrity compliance of related area. 監(jiān)督相關(guān)區(qū)域數(shù)據(jù)完整性的合規(guī)性； 7. Participate in AQL as required. 根據(jù)內(nèi)部工作分工需要參與AQL。