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Validation Professional

3 weeks ago

Nagpur, Maharashtra, India beBeeValidation Full time ₹ 20,00,000 - ₹ 25,00,000
Validation Expert Job Opportunity

About Our Role:

This is a challenging role for an experienced validation professional who can contribute to the success of our organization.

  • We are seeking a skilled Validation Engineer with expertise in computer system validation and quality compliance in FDA-regulated industries, such as medical devices, pharmaceuticals, and life sciences.

Key Requirements:

Essential Skills:
  • No less than 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.
  • Thorough understanding of fundamental cGMP concepts and FDA/EMA regulations, QSR, 21 CFR Part 820, 21 CFR Part 11, and ISO 9001 Standards.
  • Strong knowledge of FDA-regulated manufacturing processes, process validation, computer and equipment validation, and Good Manufacturing Practices (GMPs).
  • Hands-on experience in Electronic Document Management Systems (EDMS) & Test Management tools.
  • Familiarity with FDA's recent guidance on transition of Computer System Validation (CSV) to Computer System Assurance (CSA).
  • Excellent written and oral communication skills.
  • Ability to work on complex projects with general direction and minimal guidance.
  • Capacity to handle multiple projects and meet deadlines.
  • Ability to manage priorities and workflow efficiently.

The ideal candidate will possess strong technical skills and excellent communication skills, with the ability to work independently and collaboratively as part of a team.

We offer a dynamic work environment, opportunities for growth, and a chance to make a meaningful contribution to our organization.

If you have a passion for validation and are looking for a new challenge, please submit your application.