Key Responsibilities 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.
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 experience in a similar role within a sterile production environment.
Good knowledge of GMP.
Fluent in Italian.
Good knowledge of English.
Salary Expected annual Salary Base Range for the role: EUR 29,***********,******
Benefits Benefits and rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally:
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.
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📌 Quality Assurance Specialist (Montà)
🏢 Attività alberghiera
📍 Montà