Lavori attuali relativi a Computer System Validation Specialist - Milano, Lombardia - NTT DATA
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Computer System Validation Specialist
2 mesi fa
Job Title: Computer System Validation Engineer
Job Summary:
We are seeking a highly skilled Computer System Validation Engineer to join our Life Sciences Team at NTT DATA. As a key member of our team, you will be responsible for ensuring the quality and compliance of our IT systems, particularly in the context of GxP regulations.
Main Responsibilities:
- Validation Strategy and Planning: Participate in the definition of the validation strategy, specification, and design of integration, and test execution carried out by the implementation phase.
- Technical Interface: Ensure a technical interface with other professions, particularly with system, software, and product users.
- Change Request Analysis: Interpret analysis linked to change requests.
- Data Integrity Risk Assessment: Set up Data Integrity Risk Assessment for all computerized and automated systems.
- Quality and Compliance Risk Identification: Identify potential quality and compliance risks.
- QA Oversight: QA oversight in validation activities.
- Documentation Development: Develop and review departmental documentation, including training, SOPs, change controls, ensuring GMP and applicable regulatory guidelines.
- Validation Documentation: Write and implement Validation documentation (Validation Plan, Validation Summary Report, Risk Assessment, Gap Analysis, IOQ, Periodic Review).
Requirements:
- Education: Master degree in IT, Computer sciences, Industrial, Biotechnology, Chemistry, or Pharmacy.
- Experience: A first experience in IT and CSV position would be appreciated.
- Skills: Familiar with GMP environment and V cycle. Ability to understand and extract necessary information from technical documents. Good teamwork and organizational skills. Strong analytical skills. Facilitator, influencer, and planner. Good oral and written communication skills in English.
