Quality Operations Specialist

Job Description Summary

Job Description

Major Accountabilities

• Perform Batch Record Review and support timely and GMP-compliant batch release activities.
• Ensure compliant documentation lifecycle management, including review, approval, archiving, and control of paper-based and electronic records.
• Prepare, review and approve quality-related documentation, including operational procedures, protocols, work instructions, and controlled documents.
• Support deviation and complaint investigations, including impact assessments, investigation follow-up, and timely closure.
• Support CAPA, actions, change control, internal audit, and Health Authority inspection readiness activities, ensuring timely execution of defined actions.
• Perform batch-wise Audit Trail Reviews in accordance with the approved plan and applicable