Computer System Validation Associate

1 settimana fa

Bresso, Italia AGC Biologics A tempo pieno

Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.

Attività principali:

- Eseguire Assessment GxP (Electronic Record / Electronic Signature / Data Integrity)
- Preparare ed emettere i Validation Plan di sistemi computerizzati inclusi Risk Assessment di sistema
- Preparare e revisionare i documenti di convalida come IQ, OQ e PQ
- Eseguire i protocolli di IQ/OQ/PQ approvati
- Revisionare i protocolli eseguiti di IQ/OQ e PQ
- Preparare ed emettere i Validation Report di sistemi computerizzati inclusi Risk Assessment di sistema
- Preparare ed emettere, revisionare ed eseguire i protocolli di convalida di fogli di calcolo excel
- Fornire supporto per la gestione di modifiche / deviazioni e azioni correttive e preventive (CAPA), relative agli aspetti CSV
- Eseguire le attività definite nel Periodic Review Plan
- Aggiornare l’Inventario dei Sistemi Computerizzati
- Aggiornare l’Inventario dei Fogli di calcolo Excel convalidati
- Partecipare agli audit dei clienti e alle ispezioni delle autorità regolatorie per le parti di propria competenza

Requisiti:

- Esperienza: minimo 2 anni nel settore farmaceutico
- Lingua inglese: buona conoscenza sia scritta che parlata (almeno livello B2)
- Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe._
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- AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances._

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