Senior Computer System Validation Specialist

6 days ago


Nellore, Andhra Pradesh, India beBeeValidation Full time ₹ 1,50,00,000 - ₹ 2,50,00,000
About Validation Engineering Roles

We are looking for a skilled Validation Engineer to join our team.

The ideal candidate will have hands-on experience in computer system validation strategies to ensure compliance with FDA regulations.

Key responsibilities include:

  • Developing and implementing computer system validation strategies.
  • Conducting risk assessments and gap analyses.
  • Collaborating with cross-functional teams to develop quality assurance procedures.

The candidate should also have knowledge of fundamental GxP concepts, FDA/EMA regulations, QSR, 21 CFR Part 820, 21 CFR Part 11, and ISO 9001 Standards.

Requirements for the role include:

  • 5-8 years of experience in computer system validation.
  • Strong understanding of FDA's recent guidance on transition of CSV to CSA.
  • Excellent written and oral communication skills.
  • Ability to work on complex projects with minimal guidance.

This is an excellent opportunity for a motivated individual to make a real impact in the field of computer system validation.

What We Offer

A challenging and rewarding role in a dynamic industry, with opportunities for professional growth and development.

A collaborative and supportive team environment.

A competitive salary and benefits package.



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