Validation on Lab Equipment for the Micro Lab, including freezers, refrigerators and incubators. Wrote and executed the IOPQ's for equipment, wrote final reports. Re-qualification for Analytical and Development Labs including assessments, risk analysis on equipment and writing and executing PQ protocols.

Developed SOP’s and Work Instructions for the Facilities Engineering Department. Updated Faciliworks database and collected information and created spreadsheets for FDA audit

Executed IQ and OQ’s for, Reach in Refrigerators, Freezers, and Walk In Cold Rooms. Authored Final Reports, Changes and deviations for all systems within a retrofit building

Authored validation protocols, SOPs, and reports. Reviewed and completed protocols for completeness, cGxP compliance and data acceptability; and compiled datapack’s for final turnover.Authored and executed IQ and OQ’s for the Laboratory Equipment, Reach in Refrigerators, Freezers, and Incubators and executed protocols for GMP manufacturing equipment including Encapsulators, tablet presses, metal checks, blenders, tablet sorters. Authored Gxp assessments, Design Specifications, User Requirement Specifications, Validation Plans and Installation, Operational and Performance Qualifications for solid dose manufacturing