QA for QC专员

负责药品检验过程的质量监督，保证所订的各项检验操作规程符合GMP要求并贯彻执行; Responsible for quality monitoring of the QC testing to ensure all operations be executed as per SOP which comply with GMP requirements;

负责产品批检验记录的审核; Responsible for reviewing of batch analytical records for drug substances and drug products

负责QC区域相关仪器设备的放行，对报警进行评估判定，并对报警处理流程进行跟踪 Responsible for the equipment release in QC area. Assess and determine alarm in QC, follow up alarm handling process

负责审核和批准原料，辅料，中间产品, 原液和成品的质量标准，取样程序和检验程序，COA，检测方案或稳定性方案和报告 Responsible for reviewing and approval of specification, sampling procedure, test procedure, CoA, test protocol，stability protocols and reports for raw materials, excipients, intermediates, drug substances and drug products;

负责对电子数据进行批放行前审核和周期性审核，并对数据审核过程中出现的异常跟进和评估 Responsible for e-data reviewing before batch release and periodic e-data reviewing, including tracking and assessing any abnormal situation found during data reviewing;

负责QC部门相关SOP文件，QRM,质量声明, URS，验证或确认方案/报告的审核 Responsible for reviewing the QRM, quality statement, SOP, URS, validation or qualification protocol/reports related to QC department;

负责审核和批准实验室调查报告，超限事件调查表； Responsible for reviewing and approval of lab investigation report, excursion investigation form;

负责批准设备，设施，仪器，厂房及计算机化系统等放行申请，对于适用的情况，需负责确认完成DI放行前检查，更新和维护计算机化系统清单;对报警进行评估判定，并对报警处理流程进行跟踪； Responsible for approving release requests for equipment, facilities, instruments, plants and computerized system. As appropriate, confirming completion of DI check before release, updating and maintaining lists of computerized system. Assess and determine alarm in QC, follow up alarm handling process.

参与QC相关的变更、偏差的审核工作，保证偏差的及时启动和次要变更及时启动和关闭；负责偏差CAPA 有效性检查; Participate in reviewing change control and deviations related to QC. Ensure initiating deviation timely; ensure initiating and closing minor change control; Responsible for checking of effectiveness for deviation CAPA

具备医药或相关专业本科以上教育背景；从事生物药、疫苗、基因治疗、细胞治疗生产管理或质量管理相关工作5年以上

熟悉GMP/CGMP/欧盟GMP等法规;

良好的协调沟通能力, 英语读写能力良好;

管理经验更优。