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Job Details

QA Operations Specialist (345160BR)


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 - Supplier Quality & Complaints is responsible for quality assurance oversight of supplier qualification and complaints in alignment with current GMP regulations, procedures and quality systems.<br><br>Your responsibilities include, but are not limited to: <br><br>• Support QA Operations as a valued business partner, with a culture of safety, quality, delivery to patients, cost, compliance and data integrity.<br>• Provide oversight of suppliers to ensure their practices fully adhere to cGMP, including data integrity & eCompliance.<br>• Support and manage qualification of suppliers used by the Indianapolis site. <br>• Manage supplier status, supplier audits, supplier corrective actions, approved supplier list, quality agreements and change notifications.<br>• Review, approve and support change controls, investigations, complaints, procedures and training material as they relate to suppliers and complaints. <br>• Ensure timely and compliant completion of complaints and supplier investigations with appropriate CAPAs identified. Follow up on corrective and preventative actions as well as effectiveness checks, when required.<br>• Perform and oversee supplier audits, when required, and follow up on corrective actions.<br>• Perform routine metric monitoring of suppliers and customer complaints as well as annual performance metric reports.<br><br>[#video#{#400,300#}#/video#]