Quality Unit Manager

5 mesi fa

Milano, Italia Antal International A tempo pieno

Gestisce i reparti di Quality Assurance e Quality Control dello Stabilimento;
- Determina le strategie per la realizzazione degli obiettivi aziendali con articolare riguardo agli obiettivi di Quality, interagendo con tutte le funzioni aziendali;
- Garantisce il rispetto e la corretta applicazione delle policies, guidando ogni eventuale cambiamento culturale, ed è responsabile dei risultati e della corretta applicazione delle procedure aziendali nell’ambito delle funzioni della Quality Unit;
- Forma e vigila sul corretto comportamento ambientale in conformità al Sistema di Gestione Ambiente e Sicurezza adottato dall’Azienda;
- Identifica e gestisce il Budget di Quality Unit, proponendo ed implementando azioni di efficientamento al fine di mantenere e migliorare la competitività sul mercato;
- Supporta le Società Italiane del gruppo, assicurando la corretta gestione delle attività volte ad assicurare la qualità delle commesse e dei prodotti rilasciati dal sito di Milano, in particolare coordinando e controllando le attività atte a garantire la corretta gestione dei reclami, dei resi e delle non conformità ed i rapporti con gli enti pubblici competenti.
- Vigila che ogni lotto di medicinale sia prodotto e controllato con l’osservanza delle norme di legge, delle GMP e delle condizioni imposte in sede di A.I.C.;
- Rilascia i lotti per l’immissione in commercio;
- Garantisce la corretta gestione, attestazione e mantenimento della documentazione relativa ai punti 7/8 in conformità a quanto stabilito all’articolo 22, comma 2 della Direttiva 75/319/CEE;
- Controlla che, nel caso di specialità medicinali di provenienza da Paesi non appartenenti alla CEE, ogni lotto di fabbricazione importato sia oggetto di un’analisi qualitativa completa, di un’analisi quantitativa di almeno tutti i componenti attivi e di qualsiasi altra prova e verifica necessaria a garantire la qualità delle specialità medicinali nell’osservanza delle condizioni previste per l’A.I.C.;
- Gestisce le comunicazioni con AIFA, in particolar modo relativamente ad eventuali irregolarità rilevate nel prodotto sia immesso in commercio;
- Collabora attivamente alle ispezioni dell’Autorità sanitaria ed effettua le operazioni richieste dalla stessa;
- Istituisce e fa osservare programmi di igiene adeguati alle attività svolte, ivi comprese procedure concernenti lo stato di salute, l’igiene e l’abbigliamento del personale;
- Verifica, in caso di fabbricazione e/o controlli affidati a terzi, l’esistenza tra committente e fornitore di contratti chiaramente definiti che specifichino doveri, adempimenti e responsabilità delle Parti, dalla stipula del contratto fino alla commercializzazione del singolo lotto di prodotto;
- Garantisce che tutti i parametri chimici, chimico-fisici e microbiologici che definiscono la qualità e la stabilità dei medicinali prodotti siano adeguatamente controllati seguendo metodi convalidati nel rispetto delle GLP e delle GMP;
- Garantisce che l’addestramento GMP, tanto iniziale quanto continuo, del personale coinvolto nella produzione e nel controllo dei farmaci, venga effettuato e aggiornato.
- REQUISITI
- Laurea in CTF o Farmacia;
- Ottima conoscenza della lingua inglese;
- Utilizzo strumenti informatici (Posta Elettronica, Pacchetto Office, Internet);
- Padronanza norme GMP;
- Certificazione nel ruolo di Qualified Person.
- LUOGO DI LAVORO: MILANO EST
- Per favore, mandate il vostro CV con una lettera di motivazione al ruolo a:

- Ref: Quality Unit Manager & Qualified Person
- Grazie fin d’ora tutti coloro che vorranno trasmetterci il loro Cv e, in caso di mancata convocazione, considereremo il profilo professionale per eventuali future esigenze.

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