Job Description
The Quality Specialist is responsible for supporting and maintaining quality system processes in compliance with Good Manufacturing Practices (GMP), corporate quality policies, and applicable regulatory requirements. This role ensures effective management of change controls, deviations, supplier quality programs, customer complaint investigations, and continuous improvement initiatives to protect product quality and regulatory compliance. Change Control Generate change controls as applicable in accordance with current standards and procedures. Evaluate the impact of proposed changes considering validated processes, applicable regulations, and current regulatory commitments. Deviations Assess deviation impact in relation to validated processes and applicable regulations to ensure product quality attributes are not compromised. Ensure compliance with associated corrective actions within established timelines. Supplier Management Support the supplier program for direct materials or excipi...