Batch Record Specialist

Remotedxb

Full-time Bio & Pharmacology & Health
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Location
dubai, dubai emirate, United-Arab-Emirates
Posted
July 19, 2026

Job Description

Responsibilities

  • Review and verify executed batch records of APIs, drug products, primary and secondary labeling and packaging
  • Review and verify analytical data and assess quality control results against acceptable limits
  • Ensure compliance with applicable SOPs and regulatory regulations
  • Communicate with CMOs regarding missing documentation and error corrections
  • Archive batch documentation in eQMS (e.g., Veeva)
  • Report all variances, errors, and deviations to supervisor
  • Collaborate on complaint and nonconformance reports
  • Write and implement SOPs and work instructions for QA processes
  • Support inspection readiness

Requirements

  • Bachelor’s degree in health, life sciences, or related field
  • Minimum 3 years of experience in QA, commercial pharmaceutical drug manufacturing, and GMP
  • Working knowledge of FDA, EU regulatory requirements, GxP, and ICH standards