Batch Record Reviewer
Core
Review batch records to ensure compliance, data integrity, and timely release of life-saving medicines.
Role type
Quality Assurance Batch Record Reviewer
Builds
Compliant pharmaceutical production batches
Domain
Life Sciences / Pharmaceutical Manufacturing
Required skills
GMP-regulated environment experience, electronic batch record systems (MES, LIMS), quality management systems (TrackWise, SAP), ALCOA+ principles, GDP documentation practices, problem-solving
Preferred skills
Fluency in English (written and spoken)
Technologies
Syncade, DeltaV, SAP, TrackWise, LIMS
Responsibilities
Perform rigorous batch record reviews, investigate and resolve batch discrepancies, analyze process parameter failures and material consumption, draft quality impact statements, drive continuous improvement and data integrity standards
Seniority
Mid-level, hands-on IC
