Quality And Control Manager

2 giorni fa


Abano Terme, Italia Adecco Italia A tempo pieno

Consultant Milano, per piccola azienda farmaceutica in crescita, ricerca un Quality Control Manager In particolare, si occuper in prima persona delle seguenti attivit (in "Compliance" area): • Collaborare alla revisione dei documenti di produzione di lotti di intermedi e API (batch records o "cartellini" di lavorazione) al fine di permettere il rilascio del lotto da parte della Persona Qualificata e la relativa spedizione ai clienti.
• Gestire la strumentazione analitica, HPLC, UV, IR Massa, deve essere in grado di redigere da zero procedure e Sop in base ai criteri GMP e di individuare i criteri di validazione dei metodi analitici.
• Revisione di protocolli di convalide di processo e drafting dei relativi report.
• Redazione della documentazione approntata per la revisione annuale della qualit dei prodotti (PQR).
• Collaborare alla gestione del lifecycle di tutta la documentazione a carattere GMP e alla relativa archiviazione.
• Collaborare all'inserimento dati (specifiche materie prime, intermedi, IPC, prodotti finiti) all'interno del sistema ERP.
• Collaborare alla preparazione della documentazione richiesta durante gli audit clienti / Ispezioni Regolatorie Requisiti e Competenze: Il/la candidato/a ideale è in possesso dei seguenti requisiti: Requisiti Formativi e Tecnici: • Laurea specialistica in Chimica, Chimica Industriale, Chimica e Tecnologie Farmaceutiche, Farmacia.
• Conoscenza della lingua inglese (scritta).
Esperienza lavorativa pregressa: • Preferenziale background di almeno 4 anno in funzione QA relative ad API in primarie societ del settore Chimico Farmaceutico • Preferenziale esperienza nella gestione documentale in ambiente fortemente regolamentato dai correnti requisiti in ottica di "data integrity" • Esperienza nell'utilizzo di tecniche statistiche alla redazione di PQR di prodotto / sistema, all'analisi di dati e ri-occorrenza non conformit .
Si offre un contratto a tempo indeterminato e RAL commisurata all'esperienza Data inizio prevista: 01/02/2025 Categoria Professionale: Scientifico / Farmaceutico Citt : Milano (Milano) Disponibilit oraria: Full Time Data inizio prevista: 15/01/2025 Categoria Professionale: Medico Citt : Milano (Milano) Disponibilit oraria: Full Time I candidati, nel rispetto del D.lgs.
198/2006, D.lgs 215/2003 e D.lgs 216/2003, sono invitati a leggere l'informativa sulla privacy consultabile sotto il form di richiesta dati della pagina di candidatura (Regolamento UE n. 2016/679).
ATTENZIONE: Abbiamo rilevato la presenza in rete di molti annunci falsi, prendi visione dei nostri consigli per riconoscere i tentativi di truffa sulla pagina dedicata al phishing su adecco.it.
Adecco Italia S.p.A. (Aut.
Min.
Prot.
N.1100-SG del 26.11.2004).
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