Qualified Person (QP)

The Qualified Person (QP) is responsible for making disposition and release decisions for human medicinal products and Investigational Medicinal Products assembled at West, ensuring compliance with EU Directives and Good Manufacturing Practice. This role involves reviewing batch files, conducting risk assessments for deviations, and certifying batches before release to the Marketing Authorisation Holder. The QP also guides the Quality Team on regulatory compliance and supports the company's quality management system.