Qualified Person - UK

Certify and release medicinal product batches while ensuring all activities comply with regulatory requirements, GMP, GDP, and company SOPs. Lead creation, implementation, and continuous improvement of cGMPs and Quality Management Systems. Conduct external audits, manage audit response plans, and review investigation documentation for quality incidents, deviations, and CAPAs. Make decisions on the fate of change controls and complaints, and approve periodic product quality reviews. Act as a Qualified Person under EU directives and a Responsible Person (import) for human medicines. Motivate and mentor Quality team members to maintain a positive quality culture. Assist with adding Biologics to the site MIA and undertake other duties as assigned by the Head of Quality.