PrincipalAssociateQualityAssurance-FUME

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:** The Principal Associate QA-FUME is responsible for providing oversight to Houston facilities, utilities, maintenance and equipment. This position is essential for ensuring GMP compliance in the design, delivery, verification, qualification, and start up to ensure regulatory approval of the facility by regulatory agencies. **Key Objectives and Deliverables:** * Provide quality oversight for the verification and qualification of the commissioning and qualification documentation, including review of URS, test cases, protocols, discrepancies resolution, traceability matrix, summary reports, periodic reviews, etc. * Proven experience with C&Q / Verification and Validation oversight including automation and computer systems validation. * Provide technical and quality review and approval of documents to ensure compliance with Lilly Global Quality Standards and local quality procedures. * Ability to effectively review and / or redline documents to ensure quality attributes are met (i.e., deviations / observations, procedures, technical studies, validation protocols, change controls, and engineering documents). * Support the QA Compliance team and site in the execution of the site readiness plan with focus on supporting start-up and ongoing quality oversight of site FUME systems including working as part of the site Utilities Process Team and Business Quality Assurance for local computer systems. * Work with the S