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.

Responsibilities:

根据需要，准备、审核相关技术文件和提供技术支持，如:变更管理，法规注册，偏差调查，验证方案及总结报告，生产记录，规程，验证主计划, 和年度质量回顾。积极参与工艺团队以实现TS/MS目标和业务及质量目标。Prepare, review and provide technical support for preparation of relevant technical documents, as required, such as: change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, VMPs, and APRs. Participate in development and implementation of process functional teams in positive fashion to implement TS/MS objectives and deliver on business and quality objectives.领导TS/MS验证相关的中小型项目，支持并参与验证的关键项目。Lead TSMS Validation minor/moderate project. Support and participate in validation major project.做为变更所有者领导并交付验证相关的中小型变更。Working as change owner to lead and deliver validation related minor/ moderate change.做为验证的SME支持工厂的项目和持续改进项目Working as validation SME to support site project and continues improvement.起草相关验证方案及报告，领导并交付验证相关的活动Initiate related validation protocols and reports. Lead and deliver validation related activities.支持编写与验证相关的TSMS流程，做为验证的执行讲师负责交付员工验证相关的培训Support writing TSMS procedures relating to validation. Working as validation execution trainer to deliver validation related training for new employee.维护和管理验证用相关仪器和物料。Maintain and manage the validation related instruments and materials负责验证相关耗材和TSMS非GMP耗材的管理工作，包括但不限于物料采购，物料盘点等。Be responsible for validation consumables and TS/MS non-GMP consumables management, including but not limited to materials procurement, materials inventory check, etc.按时完成所需培训Complete required and assigned trainings on-time遵守公司安全政策和指导方针。Adherence to safety policies and guidelines完成主管安排的其他工作Finish the other duties assigned by supervisor

                                      
Basic Requirements:

熟悉GMP 管理规范。Familiar with GMP knowledge.具备较强的文件管理和项目管理能力Strong document management and project management skills具备较好的操作能力Strong operation skills具备较强的沟通和团队协作技能Strong communication and partnering skills.

Additional Skills/Preferences:

具备GMP实践 经验者更佳Practical GMP working experience is a plus具备良好的计算机操作能力更佳Excellent computer operation skills are a plus参与过项目管理或具备项目管理经验更佳Project experience or project management skills are a plus基本的英语商务沟通技能更佳Basic business English communication is a plus具备注射药物生产经验更佳Parenteral manufacturing experience is a plus

                                
Additional Information:

申请人将工作于笔芯无菌生产工厂的各个区域。Applicant will work in various areas within the Cartridge Parenteral Plant.能从周一到周五工作8小时。Ability to work 8 hours’ days- Monday through Friday.能够根据要求加班和轮班Able to work overtime and on rotating shifts as needed及时应对生产和项目出现的问题。Pomptly respond to issues in arising in production and projects.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and 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.

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