Quality Assurance Specialist
4 mesi fa
Holostem S.r.l. è un’azienda biotecnologica dedicata alla ricerca, sviluppo, produzione e distribuzione di prodotti per terapie avanzate, basati su colture di cellule staminali epiteliali per la terapia cellulare e genica. Holostem S.r.l. è controllata da ENEA Tech e Biomedical, una Fondazione di diritto privato vigilata dal Ministero delle Imprese e del Made in Italy
**SITO INTERNET DI HOLOSTEM S.r.l.**
**SEDE DI LAVORO**
**Modena**
**DIMENSIONE ORGANICO**
**40-60 dipendenti**
**RIFERIMENTO GERARCHICO**
**Responsabile Quality Assurance**
**PRIVACY**
L'informativa sul trattamento dei dati personali è consultabile al link Privacy Policy - Holostem S.r.l.
**DESCRIZIONE DELLA POSIZIONE E DELLE ATTIVITÀ**
Il Quality Assurance Specialist svolge attività di gestione del sistema di qualità dell’azienda, in conformità alle linee guida GMP, alle procedure e alle policy aziendali. La risorsa si occuperà principalmente di batch record review di lotti di semilavorati, prodotti finiti e media fill; nonché di preparazione di report qualitativi quali, a titolo di esempio, Product Quality Review, report di media fill ecc. La risorsa si occuperà inoltre della gestione del sistema documentale di qualità e della gestione della formazione del personale.
**Attività principali previste dal ruolo**:
- Batch record review di lotti di semilavorati e prodotti finiti;
- Gestione dei media fill (convalida dei processi produttivi in asepsi);
- Gestione di documentazione e training;
- Gestione change control
- Gestione deviazioni e CAPA;
- Gestione delle qualifiche dei fornitori.
**Il Profilo**:
**REQUISITI**
- Comprovata esperienza nella gestione del sistema di qualità in ambiente farmaceutico (buona conoscenza delle linee guida GMP, ICH ecc.);
- Ottime capacità organizzative, di lavoro in autonomia e predisposizione alla collaborazione in team;
- Grande attenzione ai dettagli;
- Spiccate capacità di comunicazione e problem solving;
- Buona conoscenza della lingua inglese.
**TIPOLOGIA DI INSERIMENTO**
Inquadramento e retribuzione da valutare in sede di selezione
Buoni pasto
**CANDIDATURA
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