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System Validation Specialist

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Chennai, Tamil Nadu, India beBeeValidation Full time ₹ 15,00,000 - ₹ 25,00,000

Job Overview

We are seeking a skilled Validation Engineer to join our team.

  • Location: Chennai, India

Key Responsibilities:

  • Develop and execute validation plans for computer systems.
  • Conduct risk assessments and implement mitigation strategies.
  • Collaborate with cross-functional teams to ensure compliance with regulatory requirements.
  • Provide technical guidance and support to project teams.

Requirements:

  • 5-8 years of experience in Computer System Validation/Quality Compliance in a FDA Regulated industry.
  • Knowledge of fundamental cGMP concepts and FDA/EMA regulations.
  • Strong understanding of GxP system, process validation, computer and equipment validation, and GMPs.
  • Hands-on experience in EDMS & Test Management tools.

Preferred Skills:

  • Ability to develop clear, concise, and timely oral and written reports.
  • Excellent written and oral communication skills.
  • Ability to work on complex projects with general direction and minimal guidance.
  • Ability to handle multiple projects and meet deadlines.
  • Ability to manage priorities and workflow.

Why Choose Us?

  • Opportunity to work on high-profile projects.
  • Collaborative and dynamic work environment.
  • Professional development and growth opportunities.