• 负责实验室的化学测试并确保测试行为符合中国 GMP和礼来 GQS601,602,603,604的要求。
To take responsibility for all chemical tests and make sure the test practice is complied with both Chinese GMP and Lilly GQS601, 602,603,604 requirements.
To take responsibility for the draft/revision for the SOP related to chemical test.
•按时完成辅料测试,中控样品测试,成品测试及稳定性样品测试。
Complete the test for excipients, in-process control samples, final product and stability test on time.
Complete complain handling on time.
•根据 GMP and GLP要求有序,有组织地书写分析工作记录单。
To prepare the analytical worksheet in order and organized format.
Complete complain handling on time.
•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.
Manage activities related to the chemical lab.
•负责对与化学测试相关的消耗品,试剂,总部/地方标准品进行管理。
Manage other activities related to the chemical test including consumables, reagents, and global /local
standards.
Perform 5S management for chemical lab.
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 and GLIMS deployment.
•作为实验室发现项/偏差的主调查人,负责实验室分析调查和发现项/偏差的调查。
Be responsible for laboratory analytical investigation and investigation for laboratory
observation/deviations as a lead investigator.
Be responsible for laboratory Change.
• 遵守HSE各项管理流程,履行安全生产职责要求。
Follow various HSE management procedures and fulfil the work safety responsibilities.