Lilly
(Sr./Principal) Associate-QA Batch Release
CN · Suzhou · China, Suzhou Manufacturing-苏州工厂 · On-site in China · Full-time · Senior
需配合美国/欧洲时区参加非工作时段电话会议
Salary not stated
AI summary
About the company
礼来(Lilly)是总部位于美国印第安纳波利斯的跨国制药企业,全球员工超5万人,专注于研发和提供改变生命的药物,助力全球健康事业。
Role overview
该岗位隶属于礼来苏州工厂质量团队,负责维护产品批放行流程、现场质量监管,参与PMX、SAP等项目,确保生产与产品质量符合法规及内部标准,需配合欧美时区参加非工作时段会议,为全职驻场岗位。
Responsibilities
- 维护ELM工厂产品批放行流程并确保合规
- 执行生产现场质量监管,控制过程与产品质量
- 作为QA代表参与PMX项目并提供质量建议
- 审核PMX项目相关文件,确保合规性
- 提供SAP质量主数据,负责胰岛素半成品等批次放行
- 审核批记录及质量文件,确保数据完整准确
- 参与内审、偏差、变更、审计及投诉相关活动
- 起草/修订职责范围内的SOP或WI
Requirements
- 本科及以上学历,药学、化学或相关专业
- 1-3年生产或QA相关工作经验
- 英语读写流利,能参与跨时区沟通
- 遵守HSE程序,及时反馈安全问题
- 需配合欧美时区参加非工作时段会议
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Excerpt
At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe…
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