Validation Specialist

4 mesi fa

Varese, Italia Jefferson Wells A tempo pieno
Per azienda operante nel settore dell'ingegneria industriale per il mondo farmaceutico, Jefferson Wells è alla ricerca di una figura di: VALIDATION SPECIALISTSCOPO DELLA POSIZIONE
Il ruolo, inserito in ambito CPS, ha lo scopo di: 
  • Essere lo specialista per la preparazione e l’esecuzione delle principali attività di validazione e convalide dei prodotti Pharma, sia in azienda che presso il cliente. 
  • Essere il garante della formazione del personale tecnico interno e del personale dei distributori sulle procedure standard da eseguire durante la validazione dei prodotti, in azienda e presso il cliente, nel rispetto delle normative di riferimento e policies aziendali. 
PRINCIPALI RESPONSABILITA'
  • Assiste per i contenuti e la fase di validazione, assieme al Project Manager e con il supporto delle funzioni tecniche e di collaudo la fase di pre fat e  fat  sulle macchine/impianti destinati al Pharma;  
  • Gestire la preparazione e l’esecuzione delle attività di validazione e convalide dei prodotti Phama verificandone la correttezza dei protocolli emessa dall’Ufficio tecnico nel rispetto delle esigenze e requisiti contrattuali dei clienti nello specifico IQ, OQ, PQ&MQ: 
    • IQ - Installation qualification: Qualifica dell'installazione dell’equipment; 
    • OQ - Operation qualification: Qualifica equipment con utilizzo di procedure validate e standard certificati;
    • PQ&MQ – Performance & Maintenance qualification: Qualifica in condizione operative con utilizzo di procedure e standard certificati.  Nello specifico MQ riguarda e qualifica il funzionamento della Macchina, manutenzione ed assiste il cliente on site (accettazione del prodotto ed hand over al cliente).  
  • Gestire, con il Project Manager e con il supporto delle funzioni tecniche aziendali competenti, la chiusura dei punti aperti e/o eventuali situazioni critiche emerse presso i clienti in fase di validazione e convalida; 
  • Garantire adeguata e costante formazione interna e presso i distributori delle procedure standard da eseguire durante la validazione dei prodotti, in azienda e presso il cliente, nel rispetto delle normative di riferimento e policies aziendali. 
  • Supportare il Responsabile CPS nel raccogliere feedback di soddisfazione cliente e nel raccogliere dati e suggerimenti dal campo al fine di integrare e/o ottimizzare le attività di collaudo e installazione dei prodotti migliorandone così la qualità e garantendo una gestione più efficiente degli stessi presso il cliente.  
  • Esegue in prima persona la validazione di prodotti Pharma ritenuti particolarmente critici per complessità, integrazione della capacità installata di validazione.
COMPETENZE TECNICHE
  • Conoscenza generale degli standard normativi, delle procedure e dei processi tipici degli ambienti e delle organizzazioni dedicate alla produzione farmaceutica.
  • Conoscenza del flusso di esecuzione tipico della validazione di macchinari in ambito farmaceutico e dei protocolli standard di riferimento.
  • Comprensione degli schemi di processo.
  • Comprensione degli schemi pneumatici ed elettrici.
  • Comprensione del disegno meccanico.
  • Buona conoscenza della lingua inglese (scritto, parlato e comprensione)

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