Qualified Person - UK

TFS HealthScience; City of Westminster; On-site; GBP 40,000 - 60,000; Part time

Job summary

A leading global Contract Research Organization is seeking a Qualified Person (QP) to ensure that medicinal products meet required quality standards prior to release. This part-time role involves QP certification, compliance with UK and EU regulatory requirements, and providing GMP guidance. Candidates must be legally eligible as QPs in the UK, have experience in pharmaceutical quality assurance, and excellent communication skills. Join a dynamic team committed to innovation and making a difference in the lives of patients.

Benefits

Competitive compensation package

Opportunities for professional growth

Qualifications

• Legally eligible to act as a Qualified Person (QP) in the UK.
• Proven experience in pharmaceutical quality assurance and QP batch release.
• Strong knowledge of UK and EU GMP and regulatory requirements.
• Experience collaborating with manufacturing sites and teams.
• Ability to work independently with limited on-site requirements.

Responsibilities

• Perform QP certification and batch release activities.
• Ensure compliance with GMP and regulatory standards.
• Review and approve manufacturing documentation.
• Provide GMP and quality guidance to sponsor teams.
• Support audits, inspections, and regulatory interactions.

Skills

Pharmaceutical quality assurance

GMP knowledge

Excellent communication

Documentation skills

Decision-making skills

Job description

About this Role

TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full-service capabilities, resourcing, and Functional Service (FSP) solutions.

The Qualified Person (QP) will be responsible for ensuring that medicinal products meet all required quality standards prior to release. This includes GMP oversight, batch certification, and compliance with UK and EU regulatory requirements.

As part of our SRS/FSP team, you will be dedicated to one sponsor in the UK,a well-established pharmaceutical company with a strong presence in health and nutrition.

This position is part-time, approximately 0.2 FTE.

Key Responsibilities

• Perform QP certification and batch release activities in accordance with UK and EU GMP.
• Ensure compliance with GMP, internal procedures, and current regulatory standards.
• Review and approve manufacturing documentation, deviations, CAPA, and change controls.
• Provide expert GMP and quality guidance to sponsor teams and stakeholders.
• Support internal and external audits, inspections, and regulatory interactions.
• Maintain oversight of quality systems related to product release.

Qualifications

• Legally eligible to act as a Qualified Person (QP) in the UK under the Human Medicines Regulations.
• Proven experience in pharmaceutical quality assurance and QP batch release.
• Strong knowledge of UK and EU GMP and associated regulatory requirements.
• Experience collaborating with manufacturing sites, CMOs, and cross-functional teams.
• Excellent communication, documentation, and decision-making skills.
• Ability to work independently with limited on-site requirements.

What We Offer

We provide a competitive compensation package and the opportunity for professional growth in a rewarding environment. You’ll join a team that values collaboration, innovation, and making a difference in the lives of patients.

A Bit More About Us

Our journey began over 27 years ago in Sweden, in the city of Lund. As a full-service, global Contract Research Organization (CRO), we build solution-driven teams working toward a healthier future. Bringing together over 800 professionals, TFS delivers tailored clinical research services in more than 40 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.

Our core values of Trust, Quality, Passion, Flexibility, and Sustainability guide our decision-making at all levels. These values foster a culture of collaboration, innovation, and excellence. Together, we make a difference.