Pds Deviations
1 settimana fa
**SCOPO DELLA POSIZIONE/RESPONSABILITÀ**:
Gestire in conformità a cGMP le attività dei progetti PDS.
Contribuisce al raggiungimento degli obiettivi "zero past due" in ambito quality, per la parte di propria competenza, e degli obiettivi RFT ed OTD.
**COMPITI SPECIFICI/ATTIVITÀ PRIMARIE**:
- 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
**REQUISITI**
**Studi/Diplomi/Corsi di formazione**:
- Laurea in Biologia, Farmacia, Chimica, CTF o Diploma ad indirizzo scientifico
**Conoscenze tecniche e informatiche**:
- Normative GMP (Eu e US);
- Pacchetto MS Office
**Esperienze professionali**:
- Almeno due anni di esperienza in QA o Produzione farmaceutica (farmaci sterili) o QC (Chimico o Micro)
**Lingue**:
- Buona conoscenza dell'inglese parlato e scritto
**DESIDERABILI**
**Tratti di personalità**:
- Problem Solving
- Buone doti di comunicazione & Negoziazione
- Buone capacità Organizzative
- Time Management
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