DPEM QA Person in Plant-Drug product external manufacturing
7 days ago
DPEM QA Person in Plant-Drug product external manufacturing (Dublin, Ireland)at Eli Lilly and CompanyMid-Senior level Not discloses Ireland Limerick, County Limerick, Ireland20 hours agoAt 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 work to discover and bring medicines to those in need, improve disease management, and contribute to our communities through philanthropy and volunteer efforts. We prioritize putting people first and are seeking individuals committed to making a positive impact worldwide.ResponsibilitiesThis role provides daily quality oversight at the Contract Manufacturing (CM) site, primarily onsite. Responsibilities include setting up processes for device assembly and packaging, supporting technical transfer until process validation, and providing guidance during routine manufacturing issues such as deviations, change controls, and procedure revisions. The QA Person may also be responsible for final batch disposition, acting as the primary contact for escalation, and ensuring batches meet specifications and comply with cGMP and regulatory standards.Key Objectives/DeliverablesUnderstand the process and equipment for their product scope, including process science, upstream/downstream effects, and failure modes.Support daily operations by developing quality systems, reviewing investigations and changes, and ensuring compliance with GMPs and Lilly standards.Contribute to a quality culture, perform investigations, troubleshoot issues, and support audits and inspections.Assist in batch release activities, including review of batch records, deviations, and issuance of Certificates of Analysis.Maintain material management and support data gathering for compliance reports.RelationshipsDevelop strong working relationships with CMs, QA/QC personnel, and internal teams to ensure adherence to quality agreements and support audits and inspections.Continuous ImprovementIdentify vulnerabilities and promote process improvements, ensuring quality initiatives are managed through GMP plans.Basic QualificationsBachelor's Degree in Pharmacy, Chemistry, Engineering, Biological Science, or related field.3-5 years supporting quality/technical functions in device assembly/packaging.Additional Skills/PreferencesRegulatory experience, technical networks, familiarity with Lilly systems (SAP, Trackwise, Q docs), and experience supporting batch release are preferred.Strong knowledge of cGMPs, excellent communication, leadership, and problem-solving skills, and ability to work independently and in a team environment.Additional InformationThis is a day shift role with potential schedule flexibility. The position requires full-time onsite presence in Dublin, Ireland, with some travel. Lilly is committed to providing accommodations for individuals with disabilities during the application process. #J-18808-Ljbffr
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