COMPUTER SYSTEM VALIDATION

1 settimana fa

Verona, Provincia di Verona, Italia Orienta A tempo pieno

Orienta Spa, Societ Benefit filiale di Verona, ricerca per societ di consulenza un/una: COMPUTER SYSTEM VALIDATION &, DATA INTEGRITY CONSULTANT – GMP Mansioni La risorsa verr inserita in progetti presso aziende farmaceutiche e produttori di API, con focus sul mondo GMP. Si occuper di attivit di convalida e gestione documentale in ambito software, sistemi di produzione e laboratori QC. In particolare: - Esecuzione di assessment GMP su sistemi computerizzati e processi digitali - Redazione della documentazione di convalida: URS, Risk Assessment, Validation Plan, IQ/OQ/PQ, SOP - Monitoraggio della compliance dei sistemi rispetto ai requisiti normativi (EU GMP Annex 11, FDA 21 CFR Part 11) - Analisi e implementazione dei principi di Data Integrity (ALCOA) - Supporto alla gestione delle deviazioni, change control e CAPA relativi ai sistemi informatizzati - Verifica periodica dei sistemi e stesura reportistica di stato - Collaborazione con QA, IT, Produzione e QC per garantire la piena conformit GMP Requisiti - Laurea in discipline scientifiche (CTF, Biotecnologie, Chimica, Ingegneria o equivalenti) - Esperienza precedente in ambito CSV in contesti GMP - Conoscenza delle normative farmaceutiche europee e FDA - Capacit di analisi, precisione e gestione documentale - Ottime competenze comunicative e attitudine alla consulenza Soft Skills - Problem solving e orientamento al cliente - Capacit di lavorare in team multidisciplinari - Autonomia operativa - Riservatezza e attenzione al dettaglio Si propone: - Inserimento diretto in azienda - CCNL applicato: Chimica Industria * 13 mensilit - Orario di lavoro: Full-time 40 ore dal lunedì al venerdì L'orario di lavoro prevede il 70% in smart working, mentre il restante 30% sar dedicato ad attivit in sede e presso i clienti assegnati per il monitoraggio dei progetti. Per i candidati residenti a Verona o nelle zone limitrofe, è richiesta una presenza in ufficio pari al 50% Sedi di lavoro indicative: VERONA - PARMA- PADOVA - MILANO Settore: Ingegneria Ruolo: IT/Technology Tipo di occupazione: Contratto a tempo determinato vetrinabakeca

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