Pds Deviations

1 mese fa

Monza, Italia Thermo Fisher Scientific A tempo pieno

In relazione alle esigenze ed ai progetti in corso di PDS, e alle indicazioni del PDS Deviations & Client Quality Team Leader:

- Partecipa attivamente a tutti gli incontri stabiliti da PDS per i progetti nuovi ed in corso di avanzamento;
- Revisiona i Quality Agreement Patheon PDS- Cliente;
- Redige la documentazione GMP critica (es. PSF, risk assessment di visual inspection, risk assessment per la valutazione dei limiti di boburden) legata a progetti PDS;
- Revisiona i Master Batch Record e i relativi allegati dei prodotti legati a progetti PDS entro le tempistiche definite dai pplan;
- Genera documentazione a supporto del rilascio dei lotti fabbricati per progetti PDS entro le tempistiche previste dai pplan;
- Esamina e gestisce i reclami ricevuti dal mercato entro le tempistiche previste da accordi tecnici e/o POS specifica, collaborando con i colleghi del Compliance e proponendo soluzioni contingenti e piani di azione finalizzati alla rimozione dei problemi riscontrati;
- Esamina e gestisce le Deviazioni e le Investigazioni, confrontandosi con i colleghi di Compliance e interagendo con le varie funzioni aziendali per la definizione delle cause e l’attuazione del piano delle azioni correttive entro le tempistiche previste da accordi tecnici e/o SOP specifica;
- Verifica, nel tempo, l’efficacia delle azioni correttive;
- Collabora con i colleghi di PDS nella organizzazione di incontri tecnici e gestionali con i clienti;
- Partecipa alle visite dei clienti ed alle ispezioni di qualità (Audit);
- Genera reportistica per progetti PDS;
- Contribuisce al raggiungimento degli obiettivi “zero past due” in ambito quality (CAPA, Reclami, Deviazioni) per la parte di propria competenza, e degli obiettivi RFT ed OTD per l’invio della documentazione al cliente ed il rilascio dei lotti;
- Collabora con i colleghi di Compliance nella revisione delle SOP di Quality System che rientrano nell’ambito del PDS;
- Esegue la valutazione e la revisione delle richieste di cambiamento dei progetti PDS;
- Partecipa attivamente ai progetti di Operational Excellence.

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