QA for QC Dry External Manufacturing

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 workbut its work worth doing. If youre driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us. About Lilly 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 workbut 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. Manufacturing & Quality Technical Hub, Hyderabad Lilly's Hyderabad hub is a first-of-its-kind technical center built to lead the manufacturing and quality science agenda for Lilly's global supply network, and the work done here reaches patients in more than 110 countries. This hub oversees contract manufacturing of starting materials and intermediates for API manufacturing in India, managing the full scientific agenda for manufacturing and quality. We're building a cutting-edge scientific organization and looking for top talent in process engineering, chemistry, analytical and data sciences to be part of it. The science you develop here doesn't stay here. It moves through Lilly's global supply network and reaches patients across more than 110 countries who are counting on it. Job Description Role Overview and Key Responsibilities The Dry Product External Manufacturing QA Representative (QA for QC) provides quality assurance oversight of Contract Manufacturing Organizations (CM's) laboratory operations, ensuring that analytical testing, data integrity practices, laboratory systems, and quality controls meet Lilly standards, cGMP requirements, and applicable regulatory expectations for CM's involved with the manufacturing and packaging of solid oral dosage forms (e.g. tablets and capsules). The QA Representative is essential for ensuring that all testing meet specifications and analysed in accordance with validated practices. The role serves as a liaison between CMs laboratory operations and Lilly and is the initial point of contact for all quality-related laboratory issues at the assigned CM. Key Objectives/Deliverables Serve as liaison between CMs and Lilly; provide quality oversight of CMs laboratory operations and acts as the initial point of contact for all laboratory related issues.Escalate quality issues at CMs to Lilly QA/QC management.Coordinate and perform QA responsibilities of lab sample shipments.Participate in regulatory inspection preparations with CMs; provide on-site support during inspections.Conduct routine review of CM laboratory practices through data integrity assessments, audit trail reviews, analytical instrument record review, and raw data traceability.Perform review and approval of documents including analytical testing methods, SOPs, method transfer and validation protocols, change control proposals, and analytical equipment qualifications.Oversee CM laboratory investigations (e.g. Out of Specification deviations) and CAPA management, providing QA review and approval of root cause analyses and effectiveness checks for laboratory-originated events.Provide QA oversight of the dry product stability program, including review of stability protocols, data, and storage condition compliance at CM sites.Participate in Annual Product Review activities, Joint Process (JPT) teams, and Post Launch Optimization (PLOT) Teams.Maintain awareness of external regulatory agency findings which individually or collectively reference the quality of the product.Basic Requirements Bachelor's degree (BS) in a science-related field such as Pharmacy, Chemistry, Biological Sciences, or related Life Sciences.At least 8 years of GMP experience, with experience in pharmaceutical laboratory quality assurance, quality control, or laboratory operations in a dry product or solid oral dosage form environment.Advance to proficiency English level.Tho .