Overview
Support GMP related activities—both operational and strategic—to ensure continuous compliance with applicable regulatory requirements, internal quality standards, and site procedures (SOPs). Actively contribute to the implementation, monitoring, and improvement of quality systems, providing expertise in GMP governance, risk management, and process oversight to maintain a robust state of control across all operations.
Key responsibilities
Drive technological and organizational improvements to enhance manufacturing quality, productivity, cost efficiency, and resource optimization.
Ensure full GMP compliance across operations, aligning site practices with company policies, standards, and regulatory requirements.
Support development and lifecycle management of new products, process improvements, and existing product enhancements.
Review and approve GMP documentation (e.g., batch records, specifications, protocols) ensuring accuracy, traceability, and compliance.
Oversee document lifecycle management (paper and electronic), ensuring proper control, data integrity, and archival.




Manage quality systems activities including deviations, CAPAs, Change Controls, complaints, and laboratory investigations (OOS/OOT/OOE).
Lead or support audits, inspections, self-inspections, training compliance, supplier qualification, and Site Master File/APQR preparation.
Contribute to continuous GMP governance and regulatory expertise development, supporting readiness for future QP responsibilities.
Essential Requirements
Scientific degree.
2/3+ years of experience in a similar role within a sterile production environment.
Good knowledge of GMP.
Fluent in Italian. Good knowledge of English.
About Novartis
Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of

📌 Quality Assurance Specialist (Italia)
🏢 Altro
📍 Italia