Computer Systems Validator

13 hours ago

Thrissur, Kerala, India beBeeValidation Full time ₹ 25,00,000 - ₹ 45,00,000

About Us:

We are a global software company with a presence across 60+ countries and a workforce of over 240,000 employees.

Job Title: Validation Engineer

Key Responsibilities:

  • Develop clear and concise reports and communicate effectively both orally and in writing.
  • Work on complex projects with minimal guidance and handle multiple tasks simultaneously.
  • Manage priorities and workflow while being adaptable to changing circumstances.

Requirements:

  • Bachelor's degree in a related field or equivalent.
  • 5-8 years of hands-on experience in Computer System Validation/Quality Compliance in a FDA-regulated industry (Medical Device/Pharma/Life Sciences) with a focus on GxP systems.
  • Knowledge of fundamental cGMP concepts, FDA/EMA regulations, QSR, 21 CFR Part 820, 21 CFR Part 11, and ISO 9001 Standards.
  • Strong understanding of FDA-regulated manufacturing processes, process validation, computer and equipment validation, and GMPs.
  • Hands-on experience with EDMS (Electronic Document Management system) & Test Management tools.

Preferred Skills:

  • Hands-on experience with Microsoft Word, Excel, PowerPoint, and Visio.
  • Hands-on experience with EDMS (Electronic Document Management system) & Test Management tools.

Our Ideal Candidate:

  • A highly motivated professional with excellent communication and problem-solving skills.
  • A team player with the ability to work collaboratively and adapt to changing priorities.

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