Batch Record Specialist

ICON plc

Mexico
Not specified; competitive within country; compreh...
Cgmp regulatory compliance knowledge
Batch documentation review experience
Clinical trial material manufacturing oversight
This role is responsible for supporting quality compliance across ICON's clinical programmes with a focus on externally manufactured Clinical Trial Materials

Job Summary

  • This role is responsible for supporting quality compliance across ICON's clinical programmes with a focus on externally manufactured Clinical Trial Materials.
  • The specialist will ensure consistent application of cGMP regulations while reviewing batch documentation, certificates of analysis, and technical reports.
  • ICON offers a competitive salary, comprehensive benefits including health insurance and retirement planning, and a diverse culture that rewards high performance.

Matching Summary

This role is responsible for supporting quality compliance across ICON's clinical programmes with a focus on externally manufactured Clinical Trial Materials.

Salary

Not specified; Competitive within country; Comprehensive benefits package included

Skills & Requirements

Must-have

  • cGMP regulatory compliance knowledge
  • batch documentation review experience
  • clinical trial material manufacturing oversight
  • deviation investigation and CAPA support
  • external CMO quality management

Nice-to-have

  • experience with US and EU regulations
  • strong stakeholder collaboration skills
  • inspection readiness participation

Key Requirements

  • Bachelor's degree in related field
  • 3+ years QA compliance or Quality Product Disposition experience
  • Working knowledge of cGMP regulations

Work Rights

Not specified

Tailored Resume

Cover Letter