Assoc. TS/MS Consultant CEM
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.
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.
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.
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.
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;
Assist Lilly external partners with technical evaluations, master planning, technology assessments, and specific problem resolution;
Support Lilly external partners to establish consistent monitoring program on process equipment to enable variability reduction, trends identification and short-term action plans;
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;
Support Lilly external partners with new product launching and change control to current process or equipment，assisting 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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