(Sr/Principle) QA Associate - FUME

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work, but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

FUME QA为灌装和包装区域的FUME相关的活动支持，对公用设施，厂房及设备的设计，调试及确认，验证提供质量监督，作为HVAC/Utility Process Team成员，对涉及的直接及间接影响系统，包括纯化水，注射用水，洁净蒸汽，洁净压缩空气，HVAC系统的日常活动提供质量监督。

Taking FUME QA role to support FUME activities in ELM and ELP, and provide QA oversight for Facility, Utility and equipment design, commission and qualification, validation. Act as a member of HVAC/Utility Process Team, provide Quality oversight for routine activities related to purified water system. WFI system, clean steam system, PCA system and HVAC system.

用户要求，规范，设计确认，安装确认，运行确认及性能确认方案及报告，工程流程文件以及其他文件的审核和/或批准，确保资产交付过程符合现行GMP，法规及礼来规程要求。

Review and/or approval of User Requirements, Specifications, Qualification packages, Engineering Flow Documents, and other documentation. Ensure asset delivery process in compliance with current GMP, regulatory and Lilly standards.

确保资产始终处于确认状态，参与维护策略制定及维护活动审核，以及AQM审核。

Ensure assets maintained in qualified state. Participate in maintenance strategy setup, provide oversight for maintenance activities and asset qualification monitoring.

参与运营团队相关活动，包括定期会议，行动追踪。作为公用设施，厂房及HVAC区域专家，持续提升运营团队对相关规定的理解。Participate in process team related activities, including periodic meeting, action track. As an SME for utilities, facility and HVAC, continuous improve process team’s understanding of related standards.

如需要，承担计算机系统QA Backup职责以及提供实验室设备管理活动的质量监督，对IT及计算机系统相关活动提供质量监督。

When required, Take backup CSQA role as necessary to provide quality oversight for computer system validation and provide quality oversight on lab equipment management

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.

#WeAreLilly