Lilly QC Technician - Biological in Suzhou Manufacturing-苏州, China
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
岗位描述/ Position Brand Description:
Participate in clean utility system monitoring and microbiological lab tests, meanwhile ensure the monitoring and the test operations are complied with both Chinese GMP and Lilly GQS requirements.
主要职能/ Key Objectives/Deliverables：
Apply HSE Procedure correctly and wear the expected PPE correctly
Apply Data Integrity requirement correctly during work.
Share event on quality and HSE inside and outside team actively.
执行洁净系统质量监测，包括饮用水、纯化水、注射用水、洁净蒸汽和洁净压缩空气系统。Perform quality monitoring for clean utility systems, including portable water system, purified water system, water for injection system, clean steam system and pharmaceutical compressed air system.
Perform QC microbiological lab release testing, include but not limited
to: Utility, IPC, excipients and PPC.
To assist with method verification and study for microbiological lab test
(including protocol draft, method verification execution, report
负责起草/修订微生物测试相关的SOP。Be responsible for the SOP draft/revision in QC microbiological lab.
参与微生物洁净室的管理。Participate in microbiological lab clean room management.
参与微生物测试相关的消耗品，试剂以及全球/本地标准品进行管理。Participate in management of consumables, reagents, and global /local standards which related to microbiological lab test.
参与微生物实验室的文件管理。Participate in document management for microbiological lab.
负责实验室日常报告的第二人复核（可选）To be responsible for the routine lab reports second person verification.
负责实验室新进人员的培训（可选）Responsible for fresh analysts’ training.
参与微生物实验室的5S管理。Participate in 5S management for microbiological lab.
做其它和质量有关的事项。To assume other tasks related to Quality.
协助GLIMS系统实施。To assist with GLIMS deployment.
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.
基本要求/ Basic Requirements:
大专及以上学历，药学生物学或相关学科。College degree or above, majored in pharmaceuticals, biological or related sciences.
Capable of writing and read in English.
Understanding of Good Manufacturing Practices.
Overtime may be required.
Working on shift may be required.
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