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Lilly (Sr.) QC Technician in Suzhou Manufacturing-苏州工厂, 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:

参与洁净系统监测和微生物实验室的测试,并确保监测和测试操作符合中国GMP和礼来GQS的要求

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:

  • 正确遵守HSE规程,在日常工作中正确穿戴PPE。 Apply HSE Procedure correctly and wear the expected PPE correctly during work.

  • 在日常工作中正确遵守数据完整性要求。 Apply Data Integrity requirement correctly during work.

  • 积极主动在团队内和团队外分享质量和安全相关的事项。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.

  • 执行微生物实验室的放行测试,包括但不限于:水系统,中控样品,原料和包材。 Perform QC microbiological lab release testing, include but not limited to: Utility, IPC, excipients and PPC.

  • 协助微生物实验室相关的方法确认和研究(包括起草方案,执行,撰写验证报告)。 To assist with method verification and study for microbiological lab test (including protocol draft, method verification execution, report generating).

  • 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.

  • 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.

  • 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.

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.

  • 能用英语写和读 。

Capable of writing and read in English .

其他要求:

Additional Preferences:

  • 了解GMP。

Understanding of Good Manufacturing Practices .

其他信息:

Other Information:

  • 可能需要加班。

Overtime may be required.

  • 可能需要轮班。

Working on shift may be required.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( LillyRecruitingCompliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

#WeAreLilly

At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people.​ We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!

#WeAreLilly

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