Computer System Validation Specialist

2 settimane fa


Milano, Lombardia, Italia NTT DATA A tempo pieno

Job Description

We are seeking a skilled Computer System Validation Specialist to join our Life Sciences Team. The ideal candidate will be involved in various stages of the validation cycle, from capturing customer needs to managing Quality Compliance of IT Systems relevant for GxP regulations. Key responsibilities include:
•Participating in the definition of the validation strategy and specification of integration.
•Ensuring a technical interface with system, software, and product users.
•Interpreting analysis linked to change requests.
•Setting up Data Integrity Risk Assessment for computerized and automated systems.
•Identifying potential quality and compliance risks.
•Providing QA oversight in validation activities.
•Developing and reviewing departmental documentation, including training, SOPs, and change controls, ensuring GMP and applicable regulatory guidelines.
•Creating and implementing validation documentation, such as Validation Plans, Validation Summary Reports, Risk Assessments, and Gap Analyses. For more information, please visit our local Career site.

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