Qualified Person

Location: Holmes Chapel

Cure Talent is delighted to partner with a well-established organisation operating across pharmaceutical manufacturing and medical device combination products, supplying both commercial and clinical products to global markets.

Due to continued growth and investment across their operations, they are now looking to appoint a Qualified Person (QP). This is a senior role within Site Quality Operations, responsible for batch certification and providing quality leadership across manufacturing and operational teams in a highly regulated environment.

About the role

As Qualified Person, you will be named on the site’s Manufacturing Licences and take responsibility for the certification and release of finished and clinical products in line with UK and EU legislation. You will act as a senior quality leader on site, ensuring GMP compliance and driving continuous improvement across Quality systems and processes.

Key responsibilities

* Certification and release of marketed and clinical product batches in line with current legislation

* Reviewing and approving batch documentation and GMP records

* Developing and approving SOPs, validation documents, investigations, and change controls

* Supporting MHRA and FDA inspections and ongoing audit readiness

* Driving continuous improvement across site Quality systems and processes

* Providing GMP guidance and coaching to site teams

Key requirements

* Qualified Person status under current UK legislation

* Degree in a relevant scientific discipline

* Strong working knowledge of cGMP in pharmaceutical manufacturing

* Experience participating in MHRA and FDA inspections

* At least 5 years’ experience within a regulated pharmaceutical environment

* Strong communication skills with the ability to influence quality culture

What’s on offer

* Senior quality leadership role within a well-established manufacturing environment

* Opportunity to influence and improve site wide Quality systems

* Competitive salary and benefits package

* Long term career development within a growing organisation

* Collaborative and quality focused working culture

* Stable business with ongoing investment in people and operations

If you are a Qualified Person (QP) looking for a new challenge within a collaborative and quality driven environment, we would love to hear from you.

For more information or a confidential discussion, hit “Apply Now” to register your interest