1.Participate in cell bank and product release activity.
參與細胞庫和產品放行工作;
2.Participate in the compliance review of Production Department (DS and 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(原液和制劑)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 (DS and DP) related quality events, including deviation, change control, CAPA, etc.
參與生產部門(原液和制劑)相關質量事件的處理,包括偏差、變更、糾正與預防措施等;
4.Lead the review of validation (or qualification) and re-validation (or re-qualification) plans and reports for equipment related to the production department (DS and DP).
領導生產部門(原液和制劑)相關設備驗證(或確認)和再驗證(或確認)方案和報告的審核;
5.Oversee GMP compliance of the operation and site management of Production department (DS and DP).
監(jiān)督生產(原液和制劑)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)督相關區(qū)域數(shù)據完整性的合規(guī)性;
7.Participate in the GMP cell bank management activities, including receiving, storage, establishment, issuance, shipment, etc.
參與GMP細胞庫的管理工作,包括接收、儲存、建庫、發(fā)放、發(fā)運等;
8.Participate in the internal audit (self-inspection), external audit and supplier audit.
參與內審(自檢)、外審和供應商審計;
9.Complete the other tasks as assigned.
完成分配的其他工作。