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QA Validation Consultant

QA Validation Consultant

Katalyst HealthCares & Life SciencesPlainsboro, NJ
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Job Description :

In this Position of IT Quality Assurance Associate, you will support implementation and operational aspects of IT systems while ensuring compliance with internal and external requirements.

Responsibilities :

  • Provide compliance guidance across IT and stakeholders, focusing on computerized system validation (CSV) in a GxP regulated environment.
  • Lead and oversee the validation and qualification processes for GxP computerized systems and infrastructure, both on-premises and cloud-based, to ensure adherence to CFR Part Compliance and other relevant regulations.
  • Review, and approve CSV lifecycle documents, including validation plans, requirements, risk assessments, and validation summary reports.
  • Evaluate new computerized systems or software for GxP impact and provide risk-based validation guidance.
  • Review incidents and changes to computer systems for GxP impact, identifying necessary validation or qualification requirements.

Requirements :

  • Bachelor's degree in computer science, Information Technology, Life Sciences, or a related field
  • Minimum of years of direct experience in validation in pharmaceutical, biotechnology, or regulated healthcare industry
  • Proven experience in IT compliance and validation within a GxP regulated environment, specifically with CFR Part compliance.
  • Strong understanding of computerized system validation principles, regulatory requirements, and quality management systems.
  • Excellent project management skills, with the ability to lead cross-functional teams and manage multiple projects simultaneously.
  • Exceptional communication and interpersonal skills, with the capacity to work collaboratively with internal and external stakeholders.
  • Detail-oriented with a strong analytical mindset and problem-solving capabilities.
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    Validation Consultant • Plainsboro, NJ