CSA & Quality Compliance Expert

ph3Perché NTT DATA? /h3pCome 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. /ppCrediamo nel talento e nell’evoluzione professionale, supportati da formazione continua, programmi di apprendimento avanzati e piani di crescita personalizzati. /ppFacciamo 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. /ppSiamo presenti in Italia con oltre 6000 dipendenti a Milano, Roma, Torino, Genova, Bologna, Treviso, Pisa, Napoli, Cosenza, Bari e Salerno. /ph3CSA Quality Compliance Expert /h3p3-5 anni di esperienza in Computer System Validation per supportare progetti di conformità e validazione per clienti, inclusi top pharmaceutical, biotech e medical device companies. /ph3Role Description /h3pIl 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. /ph3Key Responsibilities /h3ulliDraft and review validation documentation in compliance with industry regulations. /liliParticipate in validation projects for computerized systems, including ERP, MES, LIMS, SCADA and Data Integrity solutions. /liliSupport compliance projects in the Medical Device sector, ensuring adherence to ISO 13485, EU MDR and other relevant regulations. /liliPerform risk assessments and impact analyses for computerized systems in both pharma/biotech and medical device environments. /liliCollaborate with cross-functional teams, including IT, QA and operations, to ensure compliance with standards and regulations. /liliProvide support during client and regulatory audits (FDA, EMA, ISO etc.), supplying evidence and required documentation. /liliDeliver training and guidance to client personnel on validation and compliance activities for Life Science and Medical Device sectors. /li /ulh3Requirements /h3ulliDegree in scientific or technical disciplines (Engineering, Computer Science, Biotechnology, Chemistry etc.). /liliAt least 3-5 years of experience in CSA activities within Life Science. /liliSolid understanding of regulatory guidelines: GAMP 5, FDA 21 CFR Part 11, EU Annex 11. /liliExperience with risk-based validation approaches and familiarity with software validation in GxP contexts. /liliAbility to manage complex projects and effectively collaborate with clients across multiple industries. /liliExcellent analytical, planning and problem-solving skills. /liliProficiency in English, both written and spoken. /li /ulh3Sede di lavoro /h3pMilano, con possibilità di modalità di lavoro Ibrida (Smart Working). /ph3Unisciti a noi! /h3pThird 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 @ /p /p #J-18808-Ljbffr