Anu Etti

• Managed and processed change orders for Quality Documents,

ensuring 100% accuracy and compliance with ISO, FDA, and

regulatory standards

• Compiled and reviewed cross-departmental Quality documents to

support the preparation of Management Review Reports,

facilitating data-driven decision-making

• Assisted the Field Corrective Action team by distributing Field

Safety Notices (FSNs), monitoring responses, and ensuring timely

execution of Corrective and Preventive Actions (CAPA)

• Provided audit support by scribing meetings, maintaining

comprehensive records, and ensuring audit readiness

• Accurately documented production data in daily system logs,

identifying and escalating any quality or process concerns to

management

• Conducted incoming product inspections, verifying

documentation, and ensuring alignment with quality control (QC)

specifications

• Performed final product inspections, ensuring compliance with

ISO and GMP standards and maintaining zero-defect tolerance

• Calibrated and adjusted production machinery to maintain optimal

performance, contributing to increased operational efficiency