About This Expert

I specialize in global supplier qualification, which has provided me with experience interacting with multiple regulatory authorities worldwide, including the U.S. FDA, MHRA, and Swissmedic. I am also experienced in the preparation of Qualified Person (QP) declarations for various regulatory submissions, working closely with Regulatory Affairs teams. In addition, I have experience in SOP development, review, and lifecycle management, including creation and updates in compliance with GMP requirements. Furthermore, I support audit management activities by assisting audit teams with audit preparation, execution, and follow-up. This includes audit evaluation, supplier qualification processes, and tracking of audit outcomes to ensure timely and effective resolution of findings.