Validation Engineer for Computer Systems

3 settimane fa

Milano, Lombardia, Italia NTT DATA A tempo pieno

Position Overview

We are seeking a skilled Computer System Validation Engineer to join our dynamic Life Sciences Team at NTT DATA. This role involves engaging in various phases of the validation lifecycle, from understanding client requirements to overseeing the integration process, while ensuring compliance with Quality Assurance standards for IT systems relevant to GxP regulations.

Key Responsibilities:

  • Contribute to the formulation of validation strategies, including the specification and design of integration processes, as well as the execution of tests during the implementation phase.
  • Act as a technical liaison with various stakeholders, particularly system developers, software engineers, and end-users.
  • Analyze and interpret requests for changes to existing systems.
  • Conduct Data Integrity Risk Assessments for all computerized and automated systems.
  • Identify and evaluate potential quality and compliance risks.
  • Provide oversight for quality assurance activities related to validation.
  • Develop and review documentation for departmental processes, including training materials, Standard Operating Procedures (SOPs), and change controls, ensuring adherence to GMP and relevant regulatory guidelines.
  • Create and implement validation documentation such as Validation Plans, Validation Summary Reports, Risk Assessments, Gap Analyses, Installation Qualification (IQ), and Periodic Reviews.

Qualifications:

  • A Master's degree in IT, Computer Science, Industrial Engineering, Biotechnology, Chemistry, or Pharmacy.
  • Prior experience in IT and Computer System Validation roles is preferred.
  • Familiarity with GMP environments and the V-model of software development.
  • Ability to comprehend and extract critical information from technical documentation.
  • Strong teamwork and organizational capabilities, along with excellent analytical skills.
  • Proficient in facilitating discussions, influencing decisions, and planning effectively.
  • Excellent verbal and written communication skills in English.

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