Anthony Wright Email and Phone Number

In this role I was responsible for: - Writing and executing plans and documentation to specify, functionally describe, test, integrate and administer pharmaceutical manufacturing and laboratory equipment, as well as packaging lines (equipment qualification). This work followed ISPE (International Society of Pharmaceutical Engineering), GAMP (Good Automated Manufacturing Practice) standards, guidelines and lifecycle principles. I also assessed and worked with system integrators and external contractors.- Writing documentation to specify, test, describe, operate, integrate and administer the computerised systems that integrate with equipment. As well as ensuring compliance with FDA electronic record and signature requirements (21CFR11) and data integrity principles.- Qualifying facility extensions and modifications.- Carrying out change management and risk assessment activities with respect to software and equipment changes.- Writing pharmaceutical manufacturing process validation protocols to describe sampling and testing at various stages of product manufacturing.- Defending my work to FDA and customer auditors.