Global Validation Solutions, Inc.

§ Prepare Technical Transfer documentation from IPR-Carolina site to IPR Canóvanas site. § Auditing manufacturing batch records to verify process parameters § Write/review/evaluate Protocols, Technical Assessments and Technical Reports for the Transfer process according to regulatory agencies § Perform training to Manufacturing and Quality personnel on Validation process § Provide justifications for changes (via Change Control System) to the manufacturing process and/or specifications § Integrate multiple disciplines such as Engineering, Manufacturing, Planning, and Quality, among others