Location Milan, Italy
- Category Other CSA & Quality Compliance Expert with 3-5 years of experience in Computer System Validation to support compliance and validation projects for our clients, including top pharmaceutical, biotech, and medical device companies. Role Description Key Responsibilities
- Draft and review validation documentation in compliance with industry regulations.
- Participate in validation projects for computerized systems, including ERP, MES, LIMS, SCADA, and Data Integrity solutions.
- Support compliance projects in the Medical Device sector, ensuring adherence to ISO 13485, EU MDR, and other relevant regulations.
- Perform risk assessments and impact analyses for computerized systems in both pharma/biotech and medical device environments.
- Collaborate with cross-functional teams, including IT, QA, and operations, to ensure compliance with standards and regulations.
- Provide support during client and regulatory audits (FDA, EMA, ISO, etc.), supplying evidence and required documentation.
- Deliver training and guidance to client personnel on validation and compliance activities for Life Science and Medical Device sectors. **Requirements**: - Degree in scientific or technical disciplines (Engineering, Computer Science, Biotechnology, Chemistry, etc.).
- At least 3-5 years of experience in CSA activities within Life Science.




- Solid understanding of regulatory guidelines: GAMP 5, FDA 21 CFR Part 11, EU Annex 11.
- Experience with risk-based validation approaches and familiarity with software validation in GxP contexts.
- Ability to manage complex projects and effectively collaborate with clients across multiple industries.
- Excellent analytical, planning, and problem-solving skills.
- Proficiency in English, both written and spoken. Perché NTT DATA? Come società Global Top Employer abbiamo costruito un'azienda in cui la cura, l’ascolto delle persone, il loro benessere e sviluppo delle competenze sono la nostra priorità. Crediamo nel talento e nell’evoluzione professionale, supportati da aggiornamento continuo, programmi di apprendimento avanzati e piani di crescita personalizzati. Facciamo parte di NTT Group, che investe oltre 3,6 miliardi di dollari ogni anno in ricerca e sviluppo per aiutare organizzazioni e società a muoversi con fiducia e sostenibilità verso il futuro digitale. Siamo presenti in Italia con oltre 6000 dipendenti a Milano, Roma, Torino, Genova, Bologna, Treviso, Pisa, Napoli, Cosenza, Bari e Salerno_._ Sede di lavoro Milano, con possibilità di modalità di lavoro Ibrida (Smart Working). Unisciti a noi!
- third parties fraudulently posing as NTT DATA recruiters_

📌 Csa & Quality Compliance Expert (Milano)
🏢 Ntt
📍 Milano