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Batch Record Specialist

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iconplc

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Location:
Mexico , Mexico City

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Category:
Quality Control

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Contract Type:
Employment contract

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Salary:

Not provided
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Job Description:

ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. Overview: ICON plc is a world-leading healthcare intelligence and clinical research organization, proud to foster an inclusive environment that drives innovation and excellence. We are currently seeking a Quality Assurance Specialist to join our diverse and dynamic team. This role is responsible for supporting quality compliance across ICON's clinical programmes, with a particular focus on externally manufactured Clinical Trial Materials (CTM), including Finished Drug Product, clinical packaging, and labeling. This role is accountable for batch disposition for Clinical Trials Materials manufactured at CMOs.

Job Responsibility:

  • Support and execute quality oversight activities for Clinical Trial Materials manufactured at external CMOs
  • Ensure consistent application of quality compliance by aligning daily activities with applicable cGMP regulations (US, EU, and other regions as required)
  • Review batch documentation, supporting data, certificates of analysis, and technical reports for Finished Drug Product, clinical packaging, and labeling
  • Support batch disposition processes in accordance with established quality procedures and regulatory requirements
  • Facilitate and support deviation investigations, change controls, CAPAs, investigations, and nonconformance activities related to clinical manufacturing and external supply
  • Participate in inspection readiness activities and support internal, vendor, and regulatory audits and inspections
  • Identify, assess, and escalate product-related quality and regulatory issues and emerging trends
  • Work closely with Clinical Supply, Regulatory Affairs, Technical Operations, external Qualified Persons (QPs), and other stakeholders involved in external manufacturing and supply

Requirements:

  • Bachelor's degree in a related field
  • At least 3 years of relevant QA compliance and/or Quality Product Disposition experience in the pharmaceutical or biotech industry
  • Working knowledge of cGMP regulations
  • Experience reviewing manufacturing or clinical documentation
What we offer:
  • Various annual leave entitlements
  • A range of health insurance offerings to suit you and your family's needs
  • Competitive retirement planning options to help you save and plan with confidence for the future
  • Global Employee Assistance Programme (TELUS Health), providing 24-hour access to a worldwide network of over 80,000 independent, specialised professionals supporting you and your family's well-being
  • Life assurance
  • Flexible, country-specific optional benefits such as childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, and more

Additional Information:

Job Posted:
May 04, 2026

Employment Type:
Fulltime
Work Type:
Remote work
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