Qualified Person

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.

• 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

• 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

• Competitive salary and annual bonus
• Professional development and continuous training
• A supportive, quality-driven culture with opportunities to influence and improve