Cqv Intern
Morrisville, North Carolina, United States
• Completed a 10-week validation lifecycle training program which consisted of drafting documents including User Requirement Specifications, Functional Requirement Specifications, Design Reviews/Design Qualifications, System Risk Assessments, Functional Risk Assessments, Commissioning Test Protocols, Traceability Matrices, Discrepancies, Engineering Change Requests, Automation Change Requests, and Final Reports• Adhered to FDA regulations including 21 CFR 11, 210, and 211 while applying ASTM, ICH, ISA, ISO, ISPE, PIC/S, and USP guidance• Led project meetings by providing an agenda pre-meeting and a summary with action items post meeting • Presented on the complete validation lifecycle of a Single Use Bioreactor to company higher-ups • Grew professionally through professionalism and public speaking workshops