Qualification and Validation Specialist
3 settimane fa
Lavoropiu, filale di Pomezia, ricerca per azienda cliente operante nel settore farmaceutico, un qualification and validation specialist / Validazione
- qualificazione - farmaceutico
- Assicurare, attraverso il coordinamento del gruppo assegnato, la gestione delle attività dell’area Ingegneria e Qualifiche relative a Audit, Change Control, strategie di Qualifica, SOP, Risk Assessment, engineering guidelines, rivalutazioni periodiche, archivio.
Attività principali:
Subject Matter Expert e Fronter per tutta l’area di Ingegneria e Qualifiche durante audit regolatori e clienti, organizzazione delle attività di preparazione e risoluzione delle eventuali osservazioni emerse.Partecipare alla definizione delle strategie di qualifica di macchine/impianti.Referente per l’area nelle attività di valutazione e gestione dei Change Control, nella definizione delle attività e della relativa strategia di implementazione e qualifica.
Responsabile della definizione e del monitoraggio delle CAPA scaturite da Audit, Change Control e Deviazioni e delle relative tempistiche.Assicurare l’emissione e il continuo aggiornamento delle Engineering guidelines dei principali impianti ad impatto GMP e delle procedure operative di reparto.Assicurare l’emissione delle rivalutazioni periodiche degli equipment/impianti per certificarne lo stato della qualifica.Assicurare la predisposizione della documentazione di reparto necessaria alle funzioni aziendali.Assicurare la gestione e il mantenimento dell’Archivio documentale degli equipment/impianti di stabilimento.
Requisiti:
Laura in CTF, Biotecnologie o affini con esperienza in ambito Qualità ovviamente ambiente Pharma. Conoscenza inglese parlato e scrittosperienza Una risorsa con 4 / 5 anni di esperienza,
Inquadramento in base all'esperienza, possibile inquadramento C2 / C1
Luogo di lavoro:
Latina
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