CSA & Quality Compliance Expert

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 formazione continua, 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.

CSA & Quality Compliance Expert

3-5 anni di esperienza in Computer System Validation per supportare progetti di conformità e validazione per clienti, inclusi top pharmaceutical, biotech e medical device companies.

Role Description

Il candidato selezionato lavorerà come consulente su progetti client, gestendo e supportando la validazione di sistemi informativi in ambienti regolamentati. Contributo a iniziative strategiche per Life Science e Medical Device compliance, assicurando l'allineamento con requisiti regolatori, standard GxP/ISO e best practice del settore. La conoscenza della compliance dei dispositivi medici è considerata un vantaggio.

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.

Sede di lavoro

Milano, con possibilità di modalità di lavoro Ibrida (Smart Working).

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