Nephron Pharmaceuticals
West Columbia, SC, USA
Nephron Pharmaceuticals Description:
Job Purpose: The purpose of the Batch Record Review (BRR) role is to ensure that all manufacturing and packaging processes comply with regulatory standards, company policies, and quality requirements before product release. This role plays a critical part in maintaining product integrity, patient safety, and regulatory compliance by verifying that production records are complete, accurate, and meet Current Good Manufacturing Practices (cGMP) and other industry regulations (e.g., FDA, ISO). By meticulously reviewing batch documentation, identifying deviations, and ensuring corrective actions are taken, the BRR role helps prevent product defects, recalls, and compliance issues, ultimately safeguarding public health and maintaining company credibility. Essential Duties and Responsibilities: Oversee status of batches through disposition/release process and remove barriers, communicate escalations as appropriate. Performs...