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QA Operations Specialist- GMP


Security Operations


Indianapolis, Indiana, United States

766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. <br>We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!<br>Imagine what you could do here at Novartis!<br><br>The QA Operations Specialist is responsible for quality assurance oversight of manufacturing, testing and supply chain operations with current GMP regulations, procedures and quality systems..<br><br>Your responsibilities include, but are not limited to: <br><br>• Provide oversight of all production, quality control and supply chain departments to ensure their practice fully adheres to cGMP, including data integrity & eCompliance. <br>• Ensure timely escalation to management of all applicable incidents.<br>• Support commercial product FDA/Regulatory interactions for the Indianapolis site activities and products to ensure successful regulatory submissions and audits.<br>• Review, approve and support procedures, investigations, corrective and preventive actions, change controls, complaints, training and production/testing records as required.<br>• Review manufacturing batch records for product release in compliance with registrations. This includes conducting independent technical review of documentation post-execution of cGMP activities. Ensure all specifications are met and that applicable requirements are completed and acceptable.<br>• Support site Sterility Assurance program and governance to ensure compliance of site personnel and application of aseptic techniques, Site Microbiological control strategy and trending (EM and Product) and full compliance to sterile manufacturing regulations.<br>• Support QA Operations as a valued business partner, with a culture of safety, quality, delivery to patients, cost, compliance and data integrity.<br><br>Please note: This position may involve shift work which will be defined through site start up and commercialization readiness. Weekend and/or night shift work may be required.<br><br><br>