Job Description Summary
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.
Job Description
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+ experience in a similar role within a sterile production environment.
Good knowledge of GMP.
Fluent in Italian. Good knowledge of English.
Why 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 this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
At Novartis we’re committed to reimagining medicine together – and rewarding the people who make it happen.
Expected annual Salary Base Range for the role: EUR 29.800,00 - 55.300,00
Benefits and rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Skills Desired
Continuous Learning, Good Documentation Practice, Guideline, Knowledge Of Capa, Managing Ambiguity, Qa (Quality Assurance), Quality Management, Regulation, Self-Awareness, Technical KnowledgeSkills Required
- Scientific degree
- 2-3+ years experience in a similar role within a sterile production environment
- Good knowledge of GMP (Good Manufacturing Practice)
- Fluent in Italian
- Good knowledge of English
- Good Documentation Practice (GxP documentation control)
- Knowledge of CAPA management
- Experience with quality systems (deviations, change controls, complaints, OOS/OOT investigations)
- Experience supporting audits, inspections, and supplier qualification
What We Do
Novartis is an innovative medicines company. Every day, working to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide.
