769 million. That's how many lives are touched by Novartis products globally. And, while we're proud of that fact, in this world of digital and technological transformation, we must ask ourselves this: how can we continue to improve and extend even more people's lives?
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.
Your responsibilities include, but are not limited to:
* Provide oversight of all production, quality control and supply chain departments to ensure their practice fully adheres to cGMP, including data integrity & eCompliance. * Ensure timely escalation to management of all applicable incidents. * Support commercial product FDA/Regulatory interactions for the Indianapolis site activities and products to ensure successful regulatory submissions and audits. * Review, approve and support procedures, investigations, corrective and preventive actions, change controls, complaints, training and production/testing records as required. * 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. * 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. * Support QA Operations as a valued business partner, with a culture of safety, quality, delivery to patients, cost, compliance and data integrity.