SpecialistQualityControl(Analyticallab)

Brief Job Description 工作描述简述 Finish routine analytical work for products accurately. Maintain the instruments in good status, and develop professional skills. Finish routine management of reference standards / reagents / consumables to support lab tests performed smoothly. Manage specification and test method for raw materials, packaging materials and finished products in AZ China to secure the compliance with GMP, cooperate and regulatory requirements. Support other department for regulatory registration. Understand/follow/own of testing process, identify and report issue/risk within the process and drive improvement, and solve the problem within process scope. 准确及时地完成产品的检验；将仪器维护在良好的工作状态，发展专业技能；完成对照品、试剂等易耗品的日常管理，确保实验室检验工作顺利进行。 管理阿斯利康中国公司的原辅料、包装材料和成品的标准和检验方法，以确保符合药品生产质量管理规范和法规要求及阿斯利康的有关规定，协助有关部门进行质量标准法规注册。 理解、遵守、负责综合测试流程；识别、汇报综合测试流程中的问题和风险，并驱动其持续改善；能解决综合测试流程内出现的问题。 During contract manufacturing, conduct on‑site supervision of quality control‑related activities for AstraZeneca products, ensuring comply with quality specification, test methods, and regulatory requirements. 在委托生产期间，对阿斯利康产品检验相关活动进行现场监督，确保符合质量标准和检验方法等法规要求。 Typical Accountabilities 主要职责 Routine work 日常工作 • Finish the routine analytical work accurately and timely 准确及时地完成日常分析工作 • Issue the analytical method transferring and validation protocol for raw materials finish products etc., 起草原辅料/成品等分析方法转移和验证方案 • Conduct the maintenance and validation for instrument periodically based on plan and keep it in good status. 按计划定期做好仪器的维护和验证工作并使其处于良好状态。 • Double-checking the BAR. 复核批化验记录 • Responsible for the management of chemical reagents/ reference standard/ consumables, 负责化学试剂/对照品/易耗品的管理包括采购及维护安全库存 • Responsible for the handling and disposal of lab wasted articles/expire reagent/toxic substances 负责实验室废弃物品/过期试剂/剧毒品的处理和处置 • Keep the chemical lab tidy and clean at any time. 保持化学室在任何时候的整齐和清洁 • Report any deviation timely, lead major deviation/OOS investigation 及时报告偏差、领导复杂偏差/OOS的调查 • Stability study management 稳定性研究管理 • I