Quality Control Specialist

2 settimane fa


Roma, Lazio, Italia Adecco A tempo pieno
Quality Control Manager

Consultant Milano, per piccola azienda farmaceutica in crescita, ricerca un Quality Control Manager.

Responsabilità principali:
  • 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:
  • Laurea specialistica in Chimica, Chimica Industriale, Chimica e Tecnologie Farmaceutiche, Farmacia.
  • Conoscenza della lingua inglese (scritta).
  • 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 Disponibilità oraria: Full Time

Categoria professionale Scientifico / Farmaceutico - Quality Control Manager settore farmaceutico Località Milano, Milano



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