Validation Specialist
2 settimane fa
Per la sede di Latina cerchiamo un/una Validation Specialist con > 3 anni di esperienza in ambito chimico-farmaceutico, su attività CQV (Commissioning, Qualification & Validation) e, preferibilmente, anche CSV. 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 generali Laurea 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)
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QA Validation Specialist
3 settimane fa
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...
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Pharma QA Validation Specialist | GMP-Driven Validation
3 settimane fa
Roma, Italia OSI Systems A tempo pienoA leading pharmaceutical company in Italy is looking for a QA Validation Specialist for its Quality Assurance Validation Team. The role involves analysis of technical documentation, drafting validation protocols, ensuring validation compliance, conducting data analysis, and preparing reports. Candidates should have an MA degree in a relevant field, 1-2 years...
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QA Validation Specialist
2 settimane fa
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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Validation Specialist
11 ore fa
Roma, Italia agap2 Italia A tempo pienoValidation Specialist – Equipment (Pharmaceutical) Sede: Latina (LT) Tipo di Impiego: Full Time Descrizione del ruolo Per importante realtà farmaceutica, siamo alla ricerca di un/una Validation Specialist con comprovata esperienza nella validazione di equipment in ambito GMP. La risorsa sarà inserita all’interno del dipartimento di Qualità/Engineering...
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Validation Specialist
10 minuti fa
Roma, Italia agap2 Italia A tempo pienoValidation Specialist – Equipment (Pharmaceutical) Sede: Latina (LT) Tipo di Impiego: Full Time Descrizione del ruolo Per importante realtà farmaceutica, siamo alla ricerca di un/una Validation Specialist con comprovata esperienza nella validazione di equipment in ambito GMP. La risorsa sarà inserita all’interno del dipartimento di Qualità/Engineering...
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QA Validation Specialist
4 settimane fa
Roma, Italia Crazy Pizza A tempo pienoBSP Pharmaceuticals S.p. A focuses on the development and manufacturing of anticancer drugs with high potency and cytotoxic characteristics for the pharmaceutical 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
2 settimane fa
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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QA Validation Specialist
2 settimane fa
Roma, Italia Hill Intl. A tempo pienoA prominent pharmaceutical manufacturer in Italy is seeking a QA Validation Specialist for their Quality Assurance Validation Team. This full-time position involves analysis of technical documentation, defining protocols, validation compliance, and data analysis. Candidates should hold an MA degree in CTF/Chemistry and have 1-2 years of relevant experience,...
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QA Validation Specialist
2 settimane fa
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
2 settimane fa
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...
