岗位要求： 1、具备医药或相关专业本科以上教育背景。 Bachelor's or above education background in medicine or related fields. 2、至少5年的药品生产/质量管理经验，至少2年的无菌制剂生产QA经验。 Minimum 5 years of experience in pharmaceutical production/quality management, including at least 2 years of QA experience in sterile dosage form manufacturing. 3、熟悉GMP/cGMP/欧盟GMP等法规。 Be familiar with the GMP/cGMP/EU GMP regulations. 4、英语读写能力良好。 With good English reading and writing ability. 5、具备无菌药品质量管理经验。 Experience in sterile pharmaceutical quality management. 6、具备风险管理意识和持续优化思维。 Good risk management awareness and continuous optimization thinking. 7、良好的沟通能力和团队合作能力。 Good communication and teamwork skills. 岗位职责： 1、负责审批公司PFD、MBR、BPR。 Be responsible for reviewing PFD，MBR，BPR. 2、负责监管区域相关设备设施、仪器的电子数据审核。 Be responsible for the review of electronic data of relevant equipment, facilities and instruments in the supervision area. 3、负责监管区域相关SOP或GMP图纸的审核或批准。 Be responsible for overseeing the review or approval of relevant SOPs or GMP drawings in the area. 4、负责相关质量事件审批，如质量风险评估、偏差、变更、纠正与预防措施, 计算机化系统事件、配置变更等。 Be responsible for reviewing and approving the quality events, for example quality risk management, deviation, change control, corrective action and preventive action, computer system events, configuration changes. etc. 5、负责无菌制剂的目视工序的AQL 检查。 Be responsible for AQL inspection in Visual Inspection process. 6、负责无菌生产过程中CCTV 的审核。 Be responsible for reviewing CCTV in aseptic manufacturing processes. 7、负责APS 方案及其风险评估文件审批，APS 结果复核等。 Be responsible for APS protocol and risk assessment document approval, including APS result verification. 8、负责生产过程中现场监控、房间清场放行、关键工艺参数确认。 Be responsible for manufacturing on-site monitoring, room release after clearance, Critical Process Parameter confirmation, and other activities during production. 9、 参与公司内审和外审相关工作； Participate in enterprise internal and external audit related work; 10、开展虫害控制的质量管理 Quality management on pest control 11、完成直属上级交办的其他工作。 Finish the other jobs assigned by direct leader.