QUALITY ASSURANCE COMPLIANCE EXPERT

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7mqcav

Perché NTT DATA? Come società Global Top Employer abbiamo costruito un'azienda in cui la cura, l'ascolto delle persone, il loro benessere e sviluppo delle competenze sono la nostra priorità.Crediamo nel talento e nell'evoluzione competente, supportati da formazione continua, programmi di apprendimento avanzati e piani di crescita personalizzati.CSA & Quality Compliance Expert 3-5 anni di esperienza in Computer System Validation per supportare progetti di conformità e validazione per clienti, inclusi top pharmaceutical, biotech e medical device companies.Contributo a iniziative strategiche per Life Science e Medical Device compliance, assicurando l'allineamento con requisiti regolatori, standard GxP/ISO e best practice del settore. La conoscenza della compliance dei dispositivi medici è considerata un vantaggio.Key Responsibilities Draft and review validation documentation in compliance with industry regulations.Participate in validation projects for computerized systems, including ERP, MES, LIMS,



SCADA and Data Integrity solutions.Support compliance projects in the Medical Device sector, ensuring adherence to ISO 13485, EU MDR and other relevant regulations.Perform risk assessments and impact analyses for computerized systems in both pharma/biotech and medical device environments.Collaborate with cross-functional teams, including IT, QA and operations, to ensure compliance with standards and regulations.Provide support during client and regulatory audits (FDA, EMA, ISO etc.), Deliver training and guidance to client personnel on validation and compliance activities for Life Science and Medical Device sectors.Requirements Degree in scientific or technical disciplines (Engineering, Computer Science, Biotechnology, Chemistry etc.).At least 3-5 years of experience in CSA activities within Life Science.Experience with risk-based validation approaches and familiarity with software validation in GxP contexts.Ability to manage complex projects and effectively collaborate

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7mqcav