Senior Validation Specialist

4 days ago


Chennai, Tamil Nadu, India beBeeCompliance Full time US$ 9,00,000 - US$ 13,50,000
About Our Team

We are a group of professionals dedicated to delivering top-notch services in the field of computer system validation and quality compliance.

Our team is comprised of experts with extensive experience in FDA-regulated industries, including medical devices, pharmaceuticals, and life sciences. We have a proven track record of successfully implementing GxP systems and ensuring compliance with relevant regulations such as 21 CFR Part 820, 21 CFR Part 11, and ISO 9001 Standards.

Job 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;
  • Strong knowledge of fundamental cGMP concepts and FDA/EMA regulations, QSR, 21 CFR Part 820, 21 CFR Part 11, and ISO 9001 Standards;
  • Hands-on experience in EDMS (Electronic Document Management system) & Test Management tools;
Preferred Skills and Experience
  • Knowledge of Microsoft Word, Excel, PowerPoint & Visio;
  • Experience with EDMS (Electronic Document Management system) & Test Management tools;
Key Responsibilities

This role will involve:



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