Computerised System Validation Specialist, Prov
20 ore fa
Ricerchiamo per la divisione di Advisory e Consulenza alcune figure di **specialist CSV **(Computer System Validation) con esperienza operativa nel settore Life Sciences.
**Dettagli della posizione**:
- Location: On site Imola (4 posizioni: 1 Senior, 3 Junior/Mid)
- Contratto: tempo indeterminato, full time
- Riporta a: Project Leader
- Livello e inquadramento: Commisurati al livello di competenza ed esperienza maturata + bonus, formazione e piano welfare.
**Responsabilità**:
- Definizione e stesura Validation Plan, Report di Convalida, Test Plan, criteri di Accettazione, User Requirements.
- Stesura e revisione di procedure standard (SOP) e Work Instructions.
- Predisposizione dei documenti di specifiche tecniche (Design e Funzionali) e gestione delle revisioni e flussi di approvazione.
- Scrittura ed esecuzione di protocolli di test IQ/OQ/PQ per sistemi computerizzati, processi, equipment e utilities.
- Esecuzione di Impact Assessment tecnici.
- Stesura e revisione di piani di calibrazione e di manutenzione.
- Stesura e revisione di piani, test e procedure inerenti la qualifica di infrastrutture IT/OT.
**Requisiti richiesti**:
- Elevato grado di conoscenza degli standard e delle norme del settore farmaceutico (ISPE GAMP e GxP, EUDRALEX, FDA CFR 21, etc).
- Doti comunicative: Italiano e Inglese livello CEFR C1 o superiore (letto, scritto e parlato - il colloquio sarà svolto in entrambe le lingue).
- Massima professionalità e serietà, capacità di mantenere un approccio distinto e formale nei confronti di clienti e colleghi/e.
**Cosa offriamo?**
- Ampia possibilità di sviluppo di carriera.
- Training formativi interni ed esterni all'azienda
- Bonus di performance
- Pacchetto welfare
- Buoni pasto
- Straordinari retribuiti secondo normativa
MAASI Enterprises vuole essere un'azienda inclusiva ed equa, in cui accogliere e valorizzare le differenze individuali.
Crediamo nelle pari opportunità per tutti, applichiamo condizioni di lavoro eque e retribuzioni rapportate alle responsabilità assegnate, alle competenze e al merito personali.
Contratto di lavoro: Tempo pieno, Tempo indeterminato
Benefit:
- Buoni pasto
- Cellulare aziendale
- Computer aziendale
Orario:
- Dal lunedì al venerdì
Tipi di retribuzione supplementare:
- Piano incentivi
- Quattordicesima
- Straordinario
- Tredicesima
Domande di preselezione:
- Hai almeno un paio di anni di esperienza in CSV?
Sede di lavoro: Di persona
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