Qualified Person

Qualified Person (QP) – Aseptic Pharmaceuticals Location: Stoke-on-Trent (Site-Based) Hours: Full-time, with some early morning shifts Salary: Competitive + excellent benefits package About the Role We are looking for an experienced Qualified Person (QP) to join an aseptic pharmaceutical manufacturing site in Stoke-on-Trent. This is an exciting opportunity to play a critical role in ensuring the safety, quality, and compliance of sterile medicinal products manufactured on-site. As the QP, you will be responsible for the certification and release of batches in accordance with EU/UK GMP requirements. You’ll work closely with Quality, Production, Validation, and Regulatory teams, providing leadership and expert guidance to maintain the highest standards of aseptic control. Key Responsibilities * Certify and release batches of aseptically manufactured products in line with Annex 16 and applicable regulations * Ensure ongoing GMP compliance across production, quality systems, and the wider site * Provide oversight and support during aseptic operations, media fills, and environmental monitoring activities * Lead or support investigations, risk assessments, and deviation/CAPA management * Contribute to continuous improvement initiatives and audit readiness * Act as a key liaison during regulatory inspections and internal/external audits * Offer expert QP advice to cross-functional teams * Participate in early morning shifts as required to support aseptic operations About You * Eligibility to act as a Qualified Person under UK/EU Directive 2001/83/EC * Some previous experience within aseptic/sterile manufacturing preferred * Sound knowledge of MHRA/EMA requirements and GMP principles * Excellent decision-making, problem-solving, and communication skills * Collaborative, resilient, and comfortable working in a fast-paced regulated environment * Able to work on-site full-time and support early morning activities when needed What’s on Offer * Competitive salary and annual bonus * 25+ days holiday plus bank holidays * Private healthcare * Professional development and continuous training * A supportive, quality-driven culture with opportunities to influence and improve How to Apply If you’re a QP with a passion for aseptic manufacturing and want to make a real impact within a growing pharmaceutical site, we’d love to hear from you