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 competente, 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.
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).
Unisciti a noi!
Third parties fraudulently posing as NTT DATA recruiters. NTT DATA recruiters will never ask job seekers and candidates for payment or banking information during the recruitment process, for any reason. Please remain vigilant of third parties that may try to impersonate NTT DATA recruiters, either in writing or by phone, in an attempt to deceptively obtain personal data or money from you. All email communications from an NTT DATA recruiter will be associated with an @
#J-18808-Ljbffr