Role OverviewResponsible for accurate and timely review of batch records to ensure compliance with cGMP, internal quality standards, and regulatory requirements.
What You Will Do
Verify data entries, calculations, and documentation for completeness and accuracy, identify and resolve discrepancies, and ensure proper documentation and escalation of deviations, investigations, and change controls.
Why It Might Be a Fit
Support product release, maintain data integrity, and uphold product quality and patient safety.
Requirements
- Perform final review of manufacturing documentation for completeness and compliance with cGMP, SOPs, and regulatory requirements before release.
- Deliver requested lot status updates to support production and quality activities.
- Ensure that deviations, discrepancies, and non-conformances are properly documented and escalated for investigation.
- Document and report identified documentation errors to management, ensuring proper tracking for trend analysis and use in training and continuous improvement initiatives
- Support compliance and quality initiatives by partnering with QA–Manufacturing, Compliance, and Investigation groups during real-time reviews, and providing record retrieval and filing assistance across departments.
- Provide support during internal/external audits, as requested.
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