Quality Assurance Specialist

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/77wa29

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 29,800.00 - 55,300.00

Benefits

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.

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Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/77wa29