Quality and Training Technician

1 giorno fa

Bergamo, Italia Etjca Group A tempo pieno

Il nostro cliente è una storica azienda chimico-farmaceutica presente da molti anni sul territorio della provincia di Bergamo, specializzata nella produzione di API, con clienti in Italia e in diversi paesi in tutto il resto del mondo. Per avvicendamento del personale ci ha incaricati della selezione di un/una: QUALITY ASSURANCE SPECIALIST
La persona selezionata si dovrà occupare della gestione e del monitoraggio di tutte le attività necessarie per garantire la piena conformità ai requisiti previsti dalle norme GMP e dagli standard richiesti dal Sistema di Gestione Qualità in ambito chimico-farmaceutico. Programmare, preparare, condurre gli audit esterni da parte dei clienti e redigerne il CAPA, assicurandone l'implementazione.
Gestire la parte documentale di una serie di principi attivi (batch record review, gestione delle deviazioni ed incidenti, OOS, OOT, change, reclami, resi, convalide di processo, redazione PQR e doppio controllo di PQR redatti da altre risorse del QA).
QA Manager
Team di Laboratorio QC, Team Laboratorio Convalide Analitiche, Laboratorio R&D, Ufficio Assicurazione Qualità, Ufficio Regolatorio, Ufficio Corporate Quality Assurance, Ufficio Produzione e Reparti Produttivi, Area Commerciale. Esterne : Referenti tecnici di clienti e fornitori.
Laurea in Chimica/Chimica Industriale oppure in Chimica e Tecnologie Farmaceutiche oppure in Farmacia
Esperienza di almeno 5 anni in ruolo analogo, preferibilmente maturato in aziende produttrici di principi attivi.
Ottime competenze nell'utilizzo del pacchetto Office, buona dimestichezza con SW di settore e piattaforme di gestione.
Ottima conoscenza della lingua inglese soprattutto in termini orali, oltre che di lettura.
Orario di lavoro : full time 40 ore alla settimana. Lavoro a giornata dalle 8,30 alle 17,30 dal lunedì al venerdì.
Contratto a tempo indeterminato CCNL chimico-farmaceutico.
RAL da definire in base all' esperienza e alle competenze che emergeranno durante l'iter di selezione ma comunque in grado di soddisfare le candidature più qualificate
Premio produzione annuale di circa 2.500€, premio presenza, Ticket Restaurant da 8€/die, Welfare aziendale come previsto da CCNL di riferimento.

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