The Qualified Person (QP) is legal responsibility under UK and EU law, including EU Directives 2001/83, 2001/20 and 2003/94, and namely ensuring that each batch of medicinal product has been manufactured and checked in compliance with UK/EU GMP in accordance with CTA, PSF and IMPD.
Main duties and responsibilities:
Complete batch dispositions decisions as required and ensure that the appropriate systems are in place to support batch disposition
Support the site in developing policies and procedures to comply with GMP
Ensure the site team have an up to date and appropriate level of GMP knowledge
Bring to the attention of senior management any GMP non-compliance or concerns about future non-compliances
Ensuring that the appropriate systems are in place for final batch disposition
Supporting the company in client interactions as required
Providing GMP expertise in problem solving and change management
Supporting regulatory inspections and customer audits
Provide technical support to the site team in matters of regulatory compliance and product safety
Complete site training as required to ensure appropriate GMP system maintenance and site regulatory knowledge.
Assess site compliance through customer audit and appropriate management review
Support the site in obtaining competent authority registrations
Monitor product quality as needed through tracking and trending of site quality indicators
Conduct investigations and reports as required