Quality Assurance Process Associate

2 settimane fa


Italia AGC Biologics S.p.A. A tempo pieno

Quality Assurance Process Associate

At AGC Biologics, we are seeking a Quality Assurance Process Associate to join our team. This role will be responsible for managing deviations related to process production and analytical methods, conducting batch record reviews, and preparing product specification files.

Main Responsibilities:

  • Gestione deviazioni relative agli aspetti di processo produttivo e metodi analitici;
  • Eseguire le attività di batch record review;
  • Redigere product specification file/similari;
  • Partecipare attivamente alle ispezioni da parte di clienti e da parte degli enti regolatori supportando il Lead dell'unità;
  • Preparare la documentazione per l'approvazione e il rilascio dei lotti di prodotti;
  • Seguire le attività di area relative alla spedizione dei prodotti finiti;
  • Coordinare le attività di area relative alla revisione ed emissione dei Master batch record;
  • Predisporre la documentazione necessaria alle attività produttive di lotto prodotto.

Requirements:

  • Laurea in Biologia/Biotecnologie/Farmacia/CTF o similari;
  • Gradita esperienza pregressa;
  • Capacità di lavorare in team.

Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability, and Teamwork. This role is a great opportunity to contribute to our mission of delivering the highest standard of service to our clients and partners.



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