Isabela Cabral

Planning, coordination and supervision of manufacturing campaigns in upstream and downstream process validation.

Provided start-up assistance and Performed data management including scanning and verifying the Case Report forms (CRF), checking data for accuracy and completeness.

Operations, documentation and materials management and fostered a quality culture throughout the organization, leading to multiple very successful customer audits and FDA inspection with no observations.

Performed and authored investigations and developed appropriate corrective and preventive action plans. Hosted customer and regulatory audits. Interfaced with all organizational levels to ensure company compliance with FDA 210, 211, and company Standard Operating Procedures.

Managed site Documentation Group performing creation, revision and review of master production records and Managed site training activities. Wrote, revised, reviewed and approved standard operating procedures, change controls, deviations and investigations.