Erica Castillo Email and Phone Number

Qualifying new site.

Maintain the Revalidation Plan for the manufacturing and quality control facilities, utilities, and all manufacturing equipment and ensure all revalidation is performed and reported. Ensure validation studies of manufacturing and quality control equipment, facilities are completed to the required cGMP standards.Summarize studies and author validation reports in compliance with the Quality System and cGMP standards.Oversee and execute validation of production manufacturing equipment and processes. Investigate and close-out non-conformance reports/deviations associated with validation studies. Investigate and trouble shoot technical issues. Author and review Validation Standard Operating Procedures and Policies.Create PQ protocols and final report packages for new and existing equipment including autoclaves, depyrogenation ovens, vial washers, lyophilizers. Utilized temperature mapping (Kaye and Datatrace system) to validate sterilizers, warehouses and other temperature sensitive equipment.Create PV protocols and final report packages for component preparation, aseptic media fills, filling line, packaging line.