This job is with Novartis, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ business community. Please do not contact the recruiter directly. Summary The Quality Assurance Operations Specialist provides quality services in compliance with cGMP requirements and Novartis Quality Management System as defined and agreed between QOP and business partners. Manages Quality aspects & projects within area of responsibility. About the Role Major Accountabilities: Comply with internal procedures and systems, including KPI reporting, ticket management, time tracking, workflow applications, and other functional processes. Support business needs through ad hoc administrative activities, assigned tasks, trainings, and ownership of deliverables with accuracy and timeliness. Communicate regularly with customers, partners, sites, suppliers, CMOs, and internal teams to gather feedback, coordinate activities, and support service delivery. Ensure adherence to Novartis quality standards, GxP requirements, regulatory expectations, operating procedures,



and applicable legal, IT, and P&O; requirements. Create, review, analyze, and maintain GxP documentation and reports, including SOPs, working procedures, trend reports, qualification reports, technical investigations, and ad hoc reports. Support audits, quality operations, product quality compliance, regulatory workflows, CAPA management, process improvements, and Master Data Management activities as required. Manage complaints by receiving, reviewing, processing, investigating, approving, trending, reporting, and closing complaint records in applicable QMS tools. Coordinate complaint-related activities with CMOs, suppliers, Country Organizations, sites, and complaint hubs, including documentation, sample availability, supplier investigations, deviations, actions, and follow-up activities. Obligatory Requirements: Education in Pharmacy, Science, MBA, Engineering , or an equivalent qualification from a

📌 Quality Assurance Operations Specialist (India)
🏢 Novartis
📍 India