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Assoc. TS/MS Consultant CEM

Suzhou, China

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Req ID R-24235 Title Assoc. TS/MS Consultant CEM City Suzhou State / Province Shanghai Country 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.

该岗位主要负责为礼来中国内部工厂和外部合作伙伴提供技术服务和生产支持,以确保向患者提供安全有效的药品。
This position is responsible for providing technical and manufacturing expertise to support Lilly internal sites and external partners in China to assure patients have safe and efficacious drug products.

该岗位需要与礼来工程部门,生产部门、IT部门、TS/MS部门和礼来总部顾问团队合作,给中国外部制造客户提供地区性的技术解决方案咨询,并需要与礼来内部和外部团队建立密切的工作关系。

This position will need to collaborate with Lilly Engineer, Production, IT, TS/MS and Lilly global consultant to provide technical solutions consultation to China External Manufacturing Partners, and need to build close working relationship with internal and External partners.

该岗位主要专注于技术事务和项目管理相关工作,包括工艺和设备相关的公用系统,工艺设备试车及确认、自动化及计算机系统验证实施相关的技术支持和解决方案,以及DSDP日常运行过程中工艺和设备方面的问题咨询等。
This position mainly focus on technical activities and project management related tasks, will provide the technical support and solution consultation for process and equipment related utilities, equipment commissioning and qualification, automation and computerized system validation, also support the routine DS and DP operation oversight to alliance partners.

理解适用的内部工程标准和外部法规,引导和支持外部合作伙伴确保符合法规要求;

Understand all applicable Lilly corporate engineering standards and external regulatory requirement, ensure the Lilly external partners meet regulatory requirement;

按照合适的标准,在设备确认和计算机系统验证(例如CQVMP/CQVP, UR/DQ, IQ/OQ, PQ,PV)方面提供专业要求和实施策略;

Provide expertise on Requirement and implementation strategy for equipment qualification and CSV(e.g., CQVMP/CQVP, UR/DQ, IQ/OQ, PQ, PV) in accordance with applicable standard;

帮助礼来合作伙伴开展技术评估、制定计划、技术分析和解决专业问题活动;

Assist Lilly external partners with technical evaluations, master planning, technology assessments, and specific problem resolution;

支持礼来合作伙伴在工艺设备方面建立持续的监控流程来降低变异、进行趋势鉴别和制定短期行动计划;

Support Lilly external partners to establish consistent monitoring program on process equipment to enable variability reduction, trends identification and short-term action plans;

支持礼来合作伙伴应用统计方法和技术分析手段理解工艺变量和设备性能,引导效率、生产力、质量、GMP改进和安全风险消除方面的持续提升;

Support Lilly external partners in Applying statistical methods and technical analysis to understand process variability and equipment capability, and drive continuous improvement of efficiency, productivity, quality, GMP remediation and safety risk mitigation;

支持礼来合作伙伴开展新产品开发和对现有设备或者工艺的变更控制,帮助他们进行设备和新厂房设施的设计、安装、测试和释放;

Support Lilly external partners with new product launching and change control to current process or equipmentassisting them in the design, installation, testing and release of equipment and new facility;

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 ( Lilly_Recruiting_Compliance@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.

To submit resume, visit https://www.lilly.com/careers and apply to Req ID R-24235.

Lilly is an EEO/Affirmative Action Employer and 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.

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