Computer System Validation Engineer

1 mese fa

Milano, Italia Ntt Data A tempo pieno

Job Description For our fast-growing internal Life Sciences Team, we are looking for a Computer System Engineer involved in several stages of the Validation-cycle, from the upstream phase of capturing the customers' needs to the integration process as well as managing Quality Compliance of IT Systems relevant for GxP regulations. Main responsibilities of the Role:•Partecipate in the definition of the validation strategy, in the specification and design of the integration and in the test execution carried out by the implementation phase.•Ensure a technical interface with other professions particularly with the system, software, and product users.•Interpret analysis linked to change requests.•Set up Data Integrity Risk Assessment for all computerized and automated systems.•Identify potential quality and compliance risks.•QA oversight in validation activities.•Develop and review departmental documentation including training, SOP's, change controls ensuring GMP and applicable regulatory guidelines.•Write and implement Validation documentation (Validation Plan, Validation Summary Report, Risk Assessment, Gap Analysis, IOQ, Periodic Review ….). Apply from local Career site Listen to the story of Employee Voice Alejandro Hernandez Agile Coach/Digital Strategy Consultant for the Banking Sector Chile Read more Giuseppe Cuciniello International Business Development and commercial planning Italy Read more Ianca Caroline Nascimento Linhares Agility Trainee Brazil Read more Apply from local Career site Back to search results

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