Senior Validation Specialist for Global Systems

9 hours ago


Remote, Czech Republic Avenga Full time

Job Description

We are seeking an experienced Senior Validation Specialist to join our team at Avenga. This role will be responsible for ensuring the validation of computerized systems across our global operations, adhering to regulatory requirements and industry standards.

About the Role:

  • Key Responsibilities:
  • Lead validation efforts for projects and system maintenance, including authoring validation plans and reports.
  • Review software documentation according to corporate SOPs and regulatory guidance.
  • Authorize validation plans and reports, as well as review test plans and reports to ensure system readiness.
  • Verify testing plans, activities, deliverables, and records, providing consultancy on test-related deviations and corrective actions.
  • Support system audits and inspections, as well as system maintenance with validated states and permanent audit readiness.

Requirements:

  • 3+ years of experience in IT & Software Validation (CSV, GAMP), preferably in a pharma environment.
  • Familiarity with regulatory agencies, such as CFR 21 FDA Part 11 and Annex 11.
  • Excellent communication skills, with English language proficiency at B2 level.

What We Offer:

  • A competitive salary of $85,000 - $110,000 per year, based on experience.
  • A sport subscription and private healthcare package.
  • An international project portfolio and opportunities for professional growth.

About Avenga:

Avenga is a leading digital services company that empowers businesses to thrive in a rapidly changing world. Our team of experts is dedicated to delivering innovative solutions that drive success. If you're passionate about technology and committed to excellence, we invite you to join our dynamic team.



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