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QA Operation (Batch Release)

Position Overview

We are looking for an experienced QA Operation (Batch Release) professional to support GMP quality operations and batch release activities in a sterile manufacturing environment, ensuring compliant documentation and timely quality review.

About the Role

We are looking for an experienced QA Operation (Batch Release) professional to support GMP quality operations and batch release activities in a sterile manufacturing environment. This role is focused on ensuring compliant batch documentation, timely quality review, deviation and change control follow-up, and readiness of batches for QA disposition and release.

 

Key Responsibilities

  • Perform QA review of batch records and related GMP documentation for sterile manufacturing activities, ensuring accuracy, completeness, consistency, and compliance with approved procedures and data integrity requirements.
  • Support batch release processes by coordinating documentation readiness, resolving documentation gaps, and ensuring timely completion of quality review activities prior to batch disposition.
  • Review and assess deviations, investigations, CAPAs, change controls, OOS/OOT events, and other quality events for potential impact on batch quality and release decisions.
  • Ensure that sterile manufacturing batch documentation, including production records, QC results, EM data, cleaning records, equipment logs, line clearance records, and relevant quality system records, is reviewed and appropriately addressed.
  • Identify documentation errors, compliance gaps, process anomalies, and potential quality risks, and ensure proper escalation, investigation, and follow-up through the applicable quality systems.
  • Support ongoing GMP compliance, audit readiness, and inspection preparedness by maintaining high standards of documentation review, traceability, and batch release rationale.
  • Actively participate in audit and inspection preparation, lead the presentation of batch release files during audits, and provide professional responses to auditor questions related to batch documentation, quality events, and release rationale.
  • Participate in preparation and review of SOPs, batch record templates, release checklists, quality agreements, and other GMP documents related to batch release and quality operations.

 

Requirements

  • Sc. in Life Sciences, Biotechnology, Biology, Microbiology, Chemistry, Pharmacy, Chemical Engineering, or a related scientific discipline – Must.
  • Additional GMP, batch release, quality systems, aseptic processing, or contamination control training – Must.
  • 5+ years of QA, quality operations, batch release, or GMP documentation review experience in the pharmaceutical industry, experience in sterile pharmaceutical manufacturing – Must.
  • Strong practical experience with batch record review, GMP documentation, deviations, CAPA, change controls, OOS/OOT handling, and batch disposition processes – Must.
  • Good understanding of sterile manufacturing, aseptic processing, contamination control, EM, cleaning, line clearance, and data integrity principles – Must.

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