Brr & Investigations Specialist

2 settimane fa

Monza, Italia Thermo Fisher Scientific A tempo pieno

**Mansioni principali**:
Alle dipendenze del QOPS Team Leader di riferimento e del QOPS Supervisor, supporta la Persona Qualificata nel giudizio sui lotti prodotti e sull’ambiente di lavorazione, attraverso la verifica della documentazione e delle altre informazioni necessarie. Dietro la guida e il coordinamento del Team Leader effettua le indagini su problemi e deviazioni di rilevanza GMP, e si occupa dei reclami da parte dei clienti nel rispetto degli standard, delle procedure aziendali e delle normative vigenti (leggi, norme GMP, FDA, etc.).

È il punto di contatto con il cliente per quel che riguarda gli aspetti di Quality Assurance relativi alle produzioni commerciali.

COMPITI SPECIFICI/ATTIVITÀ PRIMARIE:
1. Preparazione al Rilascio dei Lotti Commerciali e Giudizio di Conformità

Dietro la guida e il coordinamento del Team Leader assicura la conformità alle specifiche dei lotti prodotti, attraverso la compilazione delle Check List di rilascio nel rispetto delle SOP, delle normative vigenti (leggi, norme GMP, FDA, etc.) e degli standard di qualità aziendali.

Supportare il Team Leader, la PQ e il Quality Operations Senior Manager nel rilascio dei lotti di prodotto, attraverso la formulazione di un giudizio di conformità del prodotto alle specifiche sulla base delle verifiche documentali effettuate, nel rispetto delle normative vigenti (leggi, norme GMP, FDA, etc.) e degli standard di qualità aziendali.

2. Gestione Deviazioni e Rapporto d’investigazione

Effettua le indagini relative alle deviazioni dal processo produttivo con lo scopo di individuarne la Root Cause attraverso una verifica documentale e una stretta collaborazione con le strutture di supporto (produzione, manutenzione, QC, Opex) nel rispetto delle SOP, delle normative vigenti (leggi, norme GMP, FDA, etc.) e degli standard di qualità aziendali.

Col supporto delle funzioni interessate propone azioni correttive e preventive allo scopo di garantire una chiusura efficace delle deviazioni nel rispetto degli standard di qualità e delle procedure aziendali.

Supporta l’archiviazione e la gestione della documentazione relativa ai batch record e alle deviazioni in accordo al Sistema Qualità e nel rispetto degli standard e delle procedure aziendali

È il punto di contatto con il cliente per la discussione dello stato delle deviazioni dal processo produttivo.

3. Gestioni reclami

Effettua le indagini relative ai reclami provenienti dai clienti attraverso la comprensione delle cause e l'identificazione delle più idonee azioni correttive o preventive avvalendosi della collaborazione delle strutture di supporto (produzione, manutenzione, QC), al fine di massimizzare la soddisfazione del cliente nei confronti del servizio ricevuto, nel rispetto delle SOP, delle normative vigenti (leggi, norme GMP, CFR 21, FDA, etc.) e degli accordi specifici sottoscritti con i clienti.

È il punto di contatto con il cliente per la discussione dello stato di avanzamento dei reclami cliente.

4. Supporto Audit

Supporto a Team Leader nella preparazione e nella gestione degli Audit clienti e degli enti regolatori.

**Requisiti**:
Laurea in CTF, Farmacia, Chimica, Biologia, analoghe lauree a indirizzo scientifico.

Conoscenze pregresse di produzione e controllo della produzione di prodotti farmaceutici

Conoscenze delle norme GMP/FDA

Buona conoscenza della lingua inglese.

Capacità di lavorare in team ed ottime doti relazionali ed organizzative.

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