Job Title: Qualified Person (QP) Location: Stoke-on-Trent Employment Type: Permanent Job Description: We are seeking an experienced Qualified Person (QP) to join our client’s Quality team in Stoke-on-Trent. This role is critical in ensuring the compliance, release, and quality assurance of sterile pharmaceutical products in accordance with Good Manufacturing Practice (GMP). Key Responsibilities: Act as a Qualified Person (QP) under EU GMP regulations for the certification and batch release of sterile medicinal products. Ensure strict compliance with GMP, MHRA, and EU regulations. Oversee Quality Management Systems (QMS) and ensure continuous improvement in quality assurance processes. Conduct audits, risk assessments, and deviation investigations to maintain high product quality and regulatory compliance. Collaborate cross-functionally with production, regulatory, and R&D teams to ensure quality standards are met. Provide leadership and training to the QA team to enhance compliance and operational efficiency. Stay updated with regulatory changes and implement necessary updates within the quality framework. Key Requirements: Legally eligible to act as a Qualified Person (QP) under EU Directive 2001/83/EC. Strong experience in sterile manufacturing environments. In-depth knowledge of GMP, QMS, CAPA, and regulatory requirements. Proven ability to manage quality assurance processes, audits, and regulatory inspections. Excellent problem-solving and decision-making skills. Strong communication and leadership abilities.