Validation Expert

5 mesi fa

Catania, Italia Randstad Italia Spa A tempo pieno

Mansione Randstad Italia, divisione In House - Specialty Pharma ricerca per strutturata multinazionale farmaceutica un Validation Expert su Catania.
Responsabilit La persona individuata si occuper di eseguire le attivit di convalida secondo le SOP di reparto e le GMP, al fine di garantire lo stato di convalida dei sistemi che supportano la produzione, nei tempi richiesti e in conformit agli standard di sicurezza e qualit .
Le attivit prevederanno: -La scrittura ed esecuzione dei protocolli di convalida, - La revisione dei documenti di convalida eseguiti da contractor esterni, -L'emissione e revisione della documentazione di convalida e delle relative SOP, assicurandone la compilazione GMP in linea ai principi ALCOA -L'esecuzione delle norme EHS per assicurare la propria sicurezza e quella del prodotto -Collaborazione con il team delle investigazioni nell'identificare la root cause e definire le appropriate azioni correttive/preventive.
Competenze Competenze e requisiti: - Laurea in discipline scientifiche (Chimica, Ingegneria, Farmacia, Biologia o CTF o simile) - Ottima conoscenza dei processi di sterilizzazione e delle qualifiche degli equipment - Ottima conoscenza della lingua inglese, sia orale che scritta ad un livello medio alto - Ottima conoscenza delle GMP e della gestione della qualit attraverso i diversi sistemi di qualit - Esperienza in Convalida di Processo, Media Fills, Convalida del Cleaning, Convalida dei sistemi contenitore/chiusura, Convalida di ambienti a contaminazione controllata, Convalida delle attivit di Packaging ed Equipment, convalida delle CTUs - Conoscenza dei processi di produzione in asepsi e dei parametri critici - Capacit interpersonali, organizzative, di leadership e di comunicazione Si offre contratto di somministrazione iniziale a tempo determinato con possibilit di crescita personale e professionale, e livello da definire sulla base della reale esperienza del candidato.
La ricerca è rivolta ai candidati ambosessi (L.903/77).
Ti preghiamo di leggere l'informativa sulla privacy Randstad ( ai sensi dell'art.
13 del Regolamento (UE) 2016/679 sulla protezione dei dati (GDPR).
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