岗位职责: Job Responsibilities: 进行仓库质量运作整体管理,确保柯乾临床供应链运营符合质量要求。 Responsible for the overall management of warehouse quality operation to ensure that the operation of ClinsChain clinical supply chain meets the quality requirements. 确保质量体系工作有效进行和落实,包括但不仅限于文控、培训、偏差和投诉、CAPA、变更、供应商管理、验证和确认、校准、PPM、内审和外审、召回等。 Ensure effective implementation of quality system, including but not limited to document control, training, deviation, and complaint, CAPA, change control, supplier management, validation and qualification, calibration, PPM, self-inspection and external audit, recall, etc. 进行质量流程的监控和不断更新优化。 Monitor the quality process and constantly update and optimize. 参与支持现场质量检查工作,包括收货、贴签等 Participate in and support on-site quality inspection, including receiving goods, labeling, and packaging, etc. 参与内外审计,包括柯乾内审、供应商审计,以及应对国内外客户审计 Participate in internal and external audits, including ClinsChain self-inspection, supplier audit, and deal with domestic and foreign customer audit. 支持国际第三方仓库质量管理工作 Support international third-party warehouse quality management 能熟练使用英文书写质量文件,并使用英文邮件进行工作交流 Enable to draft quality related documents and communicate during work in English proficiently 经验要求 Job requirements: 有药品生产QA工作经验,或临床药品供应链质量管理经验 Experience in Pharmaceutical manufacturing QA or clinical drug supply chain quality management. 有质量主管工作经验,操作过质量管理系统,对文控、培训、偏差、变更和CAPA、供应商管理等做过独立完整的管理工作。 Working experience as quality supervisor, operating quality management system, independent and complete management of document control, training, deviation, change control, CAPA, supplier management, etc. 英文听说读写流利, Fluent in English listening, speaking, reading, and writing; 办公自动化熟练操作。 Proficient in MS office software 有在MNC药企质量部门工作经验优先。 working experience in quality department of MNC pharmaceutical company is preferred.