Amneal Pharmaceuticals LLC (J0P)
Piscataway, NJ
Description:
Responsible for the accurate and timely review of batch records to ensure compliance with cGMP, internal quality standards, and regulatory requirements. This role involves verifying data entries, calculations, and documentation for completeness and accuracy, identifying and resolving discrepancies, and ensuring that all deviations, investigations, and change controls are properly documented and addressed. The reviewer works closely with Production, Quality Assurance, and other cross-functional teams to support product release, maintain data integrity, and uphold product quality and patient safety.
Essential Functions:
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...