Quality Assurance Specialist

4 mesi fa


Modena, Italia Holostem S.r.l A tempo pieno

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

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