• Perform Incoming Inspection / Approval on Receiving and Returns material. • Perform secondary labelling and packaging quality inspection. • Perform pre and post review and approval of production batch records. • Perform QA release of finished products in GPMS and adjust inventory status of warehouse materials. • Perform QA inspection in distribution process. • Responsible for self-inspection management. • Responsible for the management of recall/ mock recall. • Responsible for document control and training management. • Responsible for medical device First-time qualification of medical device provider, client and related products. • Responsible for medical device GSP incoming inspection. • Responsible for medical device GSP sales order approval. • Monitor facility environment condition, including environmental/calibration/maintenance/pest control activities verification and Business continuity planning program management etc. • Assist to manage and monitor GxP related change to ensure that can identify the potential risk and take the mitigation action. • Assist in regulatory and client audits. • Perform ad-hoc duties as requested by line management. • 执行来料检查及收货和退货物料的审批工作。 • 执行二次包装和贴标的质量检查工作。 • 执行生产批记录的审核及批准，包括生产前和生产后的记录审查。 • 在 GPMS 系统中执行成品放行，并调整仓库物料库存状态。 • 执行发货过程中的质量检查。 • 负责内审工作。 • 负责召回/模拟召回工作。 • 负责文件管理和培训工作。 • 负责医疗器械经营产品/购货者/供应商首营审核工作。 • 负责医疗器械经营质量验收工作。 • 负责医疗器械经营销售订单审核工作。 • 监控设施环境状况，包括环境监测、校准/维护/虫害控制活动确认，以及业务连续性计划项目管理等。 • 协助管理和监督 GxP 相关变更，确保识别潜在风险并采取适当的风险缓解措施。 • 协助应对法规机构检查及客户审计。 • 完成直属领导安排的其他临时性工作。 • Education: Bachelor's or above degree in laboratory medicine or related disciplines, including Laboratory Medicine, Biomedical Engineering, Biochemistry, Immunology, Genetics, Pharmacy, Biotechnology, Clinical Medicine, Medical Devices • Years of Experience: ＞3 years quality assurance or quality control working experience; 1-2 years working experience in pharmaceutical industry; experience medical device GSP will be privileged. • Accept working in a cold storage environment (2–8°C). • 具有检验学相关专业（包括检验学、生物医学工程、生物化学、免疫学、基因学、药学、生物技术、临床医学、医疗器械专业）本科以上学历 • 3年以上质量保证或质量控制工作经验；1-2年医药行业质量管理工作经验；有医疗器械经营质量管理经验优先考虑。 • 能接受有冷库环境（2-8℃）工作。

• Advanced understanding and grasp of quality management, GxP, preferably the knowledge of clinical trial materials and medical device GSP. Knowledge in supply chain or warehouse operation will be plus. • Good communication skills. Good written and spoken English. Problem solving / Decision making ability. • 对质量管理、GxP有深入的了解和掌握，有临床试验和医疗器械经营经验者优先。有供应链或仓库操作经验者优先。 • 良好的沟通能力。良好的英语读写能力。有解决问题的能力。