Quality and Control Manager
2 settimane fa
In particolare, si occuperà in prima persona delle seguenti attività (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 qualità 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 società 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 conformità.
Si offre un contratto a tempo indeterminato e RAL commisurata all'esperienza
Data inizio prevista: 23/11/2024
Categoria Professionale: Assistenziale / Paramedico / Tecnico
Settore: INDUSTRIA CHIMICA/ CHIMICA-FARMACEUTICA
Città: Milano (Milano)
Disponibilità 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).
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