Validation Specialist

4 days ago


Thāne, Maharashtra, India beBeevalidation Full time ₹ 1,20,00,000 - ₹ 2,00,00,000
Job Overview

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

Responsibilities and Requirements
  • Validate computer systems and ensure quality compliance in FDA-regulated industries, including medical devices, pharmaceuticals, and life sciences.
  • Possess fundamental knowledge of cGMP concepts, FDA/EMA regulations, QSR, 21 CFR Part 820, 21 CFR Part 11, and ISO 9001 Standards.
  • Have strong understanding of FDA-regulated manufacturing processes, process validation, computer and equipment validation, and GMPs.
  • Be proficient in Electronic Document Management Systems (EDMS) and Test Management tools.
  • Knowledge of recent FDA guidance on transition of Computerized System Validation (CSV) to Computerized System Assurance (CSA).
  • Excellent written and oral communication skills.
  • Ability to work independently with minimal supervision.
  • Project management skills with ability to handle multiple tasks and meet deadlines.
What We Offer

Our company offers a collaborative and dynamic work environment, opportunities for professional growth and development, and competitive compensation packages.

About Us

Our organization is a global technology partner that provides cutting-edge solutions in various domains. We strive to deliver high-quality products and services that meet the evolving needs of our clients.



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