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Pharma QA Validation Specialist | GMP-Driven Validation
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giuliano di roma, Italia OSI Systems A tempo pienoBSP Pharmaceuticals S.p. A is focused on the development and manufacturing of anticancer drugs with high potency and cytotoxic characteristics for the Pharmaceuticals Industry.BSP has been at the forefront in the fight against cancer since 2006.Innovation is the hallmark of BSP with investments in new technologies and production methods in a high containment...
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QA Validation Specialist
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Giuliano di Roma, Italia Hill Intl. A tempo pienoBSP Pharmaceuticals S.p. A is focused on the development and manufacturing of anticancer drugs with high potency and cytotoxic characteristics for the Pharmaceuticals Industry. BSP has been at the forefront in the fight against cancer since 2006. Innovation is the hallmark of BSP with investments in new technologies and production methods in a high...
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EQUIPMENT VALIDATION SPECIALIST
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Validation Specialist
3 ore fa
Per la sede diLatinacerchiamo un/unaValidation Specialistcon> 3 anni di esperienzain ambitochimico-farmaceutico, su attivitàCQV (Commissioning, Qualification & Validation)e, preferibilmente, ancheCSV.Cosa farai (attività principali)Esecuzione di test in campo e compilazione protocolli ( IQ/OQ/PQ ) su impianti e sistemi (es. HVAC , utilities, linee di produzione/confezionamento, sistemi SCADA/PLC/HMI ).Stesura e/o revisione documentazione di qualifica/convalida (es. URS/FRS , protocolli, report, summary).Gestione evidenze, tracciabilità, deviazioni e chiusura attività con approccio risk-based .Interfaccia con produzione, ingegneria, QA e fornitori durante fasi di test e rilascio.Requisiti tecnici (Must have)Esperienza pratica su IQ/OQ/PQ e test in campo.Buona conoscenza GMP e Data Integrity (ALCOA+) .Familiarità con strumentazione di qualifica (es. datalogger per mappature termo-igrometriche, balometro, anemometro, fotometro, validator o equivalenti).Capacità di redigere report e validation/qualification summary .Ottima padronanza di Microsoft Word (formattazione professionale, gestione allegati/evidenze).CSV (Preferibile / Plus)Approccio risk-based e riferimenti: EU GMP Annex 11 , GAMP 5 (e 21 CFR Part 11 se applicabile).Contributo a documenti CSV: CSV Plan/VMP , Risk Assessment , Traceability Matrix , Validation Summary Report .Supporto a FAT/SAT , gestione deviation e CAPA .Verifica requisiti Annex 11/Part 11: accessi/ruoli, audit trail , backup/restore, change control, periodic review.Requisiti generaliLaurea scientifica (es. Ingegneria, Chimica, Ingegneria Meccanica, CTF o affini).Inglese buono scritto e parlato.Autonomia operativa, problem solving, approccio "hands-on"Candidatura:inviare CV a(includendo autorizzazione al trattamento dati per finalità di selezione)
