Batch Record Specialist

ICON plc

Mexico
Not specified; competitive salary mentioned; compr...
3 years qa compliance experience
Cgmp regulations knowledge
Batch documentation review skills
This role is accountable for batch disposition for Clinical Trials Materials manufactured at external Contract Manufacturing Organizations (CMOs)

Job Summary

  • This role is accountable for batch disposition for Clinical Trials Materials manufactured at external Contract Manufacturing Organizations (CMOs).
  • The successful candidate will ensure consistent application of quality compliance by aligning daily activities with applicable cGMP regulations across US, EU, and other regions.
  • ICON offers a comprehensive range of benefits including health insurance, retirement planning, and a global Employee Assistance Programme to support well-being.

Matching Summary

This role is accountable for batch disposition for Clinical Trials Materials manufactured at external Contract Manufacturing Organizations (CMOs).

Salary

Not specified; Competitive salary mentioned; Comprehensive benefits package offered

Skills & Requirements

Must-have

  • 3 years QA compliance experience
  • cGMP regulations knowledge
  • Batch documentation review skills
  • Clinical Trial Materials oversight
  • Deviation investigation support

Nice-to-have

  • Experience with external CMOs
  • Knowledge of US and EU regulations
  • Audit inspection readiness support
  • Collaboration with Qualified Persons

Key Requirements

  • Bachelor's degree in related field
  • Minimum 3 years relevant QA experience
  • Working knowledge of cGMP regulations

Work Rights

Not specified

Tailored Resume

Cover Letter