职务描述 负责化学成品实验室的测试并确保测试行为符合中国GMP和礼来GQS的要求。 Be responsible for chemical-drug product tests and make sure the test practice is complied with both Chinese GMP and Lilly GQS requirements. 按时完成中控样品测试,成品测试及稳定性样品测试。 Complete the test for in-process control samples, release product and stability test on time. 按时完成投诉样品的处理。 Complete complain handling on time. 负责起草/修订化学测试相关的SOP。 Be responsible for the SOP draft/revision in QC chemistry incoming lab. 根据GMP and GLP要求有序,有组织地书写分析报告。 To prepare the analytical reports in order and organized format. 负责化学实验室的文件管理。 Be responsible for document management for chemical lab. 负责化学实验室的5S管理。 perform 5S management for chemical lab. 做其他与质量相关的事项。 To assume other tasks related to Quality. 协助实验室质量体系的持续改进提高和GLIMS系统实施。 To assist with lab quality system continuously improvement. 通过日常的清洁和良好的保养工作,保证实验室有一个清洁、安全的环境,操作过程中严格遵守公司HSE的相关规定,避免伤害事故的发生。 To maintain lab in clean and safe condition by routinely cleaning and good housekeeping. Must follow up HSE related requirement when performing testing to avoid accident happened. 能用英语说,写和读。 Capable of speaking, writing and read in English fluently. 本科学历或以上,药学化学或相关学科。 Junior college or above, majored in pharmaceuticals, chemistry, or related sciences. 根据生产需要能够进行适当的轮班工作。 To support suitable shift work according to production requirement.