Eli Lilly and Company(Sr./Principal) Biologist-QC
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 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.
- 负责微生物实验室文件体系的管理，撰写/修订/审阅SOP/WI/Method等，确保符合GMP/药典/礼来总部文件的要求；
Responsible for managing the documentation system of the microbiology laboratory, including drafting, revising, reviewing SOPs/WIs/Methods to ensure compliance with GMP, pharmacopeia requirements, and Lilly global documentation standards.
- 领导微生物实验室方法转移/开发/确认/验证等；
Lead microbiology laboratory method transfer/ development/ verification/ validation.
- 负责微生物实验室变更管理及偏差/OOS调查等；
Responsible for change control and deviation/OOS investigations in the microbiology laboratory.
- 负责按时微生物实验室的数据审核及释放，确保满足GDP和DI要求；
Responsible for timely data review and release for the microbiology laboratory, ensuring full compliance with GDP and data integrity (DI) requirements.
- 负责微生物实验室持续改进相关项目，具备改善的思维并主动寻求改变；
Responsible for continuous improvement projects in the microbiology laboratory, demonstrating a mindset for improvement and proactively seeking opportunities for change.
- 做为微生物专家，定期组织技术分享微生物相关技术，技术指导执行团队，支持解决执行团队的技术问题；
As a microbiology subject matter expert, regularly organize technical‑sharing sessions on microbiology‑related topics, provide technical guidance to the execution team, and support the resolution of technical issues encountered during laboratory operations.
- 做为微生物专家，参与并支持微生物实验室设备确认及设备软件升级项目；
As a microbiology subject matter expert, participate in and support equipment qualification and software upgrade projects for microbiology laboratory instruments.
- 做为微生物专家，参与并支持工厂相关项目的实施，如工艺验证，无菌模拟灌装，清洁验证，灭菌验证等；
As a microbiology subject matter expert, participate in and support the implementation of plant‑related projects, such as process validation, aseptic media fill/aseptic simulation, cleaning validation, and sterilization validation.
- 做为微生物专家，参与并支持global项目的本地实施；
As a microbiology subject matter expert, participate in and support the local implementation of global projects.
- 支持实验室的日常运行工作；
To support routine operation of microbiology lab.
- 负责其他主管安排的工作；
Responsible for other tasks assigned by the supervisor.
- 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.
- 遵守Compliance各项管理流程；
Follow various compliance management procedures.
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