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