Quality Assurance Lead – GMP/GDP (EU)

R Dpartners; Slough; On-site; GBP 42,000 - 65,000; Full time

Job summary

R&D Partners in Slough invites a Quality Specialist to join a leading pharmaceutical company on a 12-month contract. The role focuses on supporting the Quality Management System and ensuring GMP/GDP compliance across the EU.

You will work with Affiliate Management, Market Quality, and Regulatory teams to drive CAPAs, deviations, change controls, and product release readiness, while maintaining training matrices and supporting regulatory inspections.

Qualifications

• Bachelor's degree in Life Sciences required.
• Minimum 5 years in pharmaceutical quality role preferred; strong qualifications considered with less experience.
• Experience in GDP environment is advantageous.

Responsibilities

• Support the Quality Management System (QMS) maintenance and deviations/changes/complaints in line with procedures.
• Collaborate with Affiliate Management, Market Quality, Global Quality, Supply Chain, Pharmacovigilance, and Regulatory teams to ensure timely GxP operations.
• Provide SME input and represent Quality in meetings, projects, and initiatives.
• Identify quality issues and drive corrective/preventive actions (CAPAs).
• Track and trend quality system data and KPIs; generate Annual Product Quality Reviews.
• Maintain training curricula and matrices for the Quality Department.
• Manage product traceability, including recalls or suspected falsified products.
• Coordinate the local stability program and support compassionate use supply.
• Contribute to affiliate self-inspections and management reviews of quality systems.
• Prepare for regulatory inspections and address deficiencies through CAPAs.

Skills

Quality assurance

GxP

CAPA management

Documentation

Stakeholder collaboration

Regulatory inspections

Attention to detail

Communication

Independent & team work

Education

Bachelor's degree in Life Sciences

Job description

R&D Partners in Slough invites a Quality Specialist to join a leading pharmaceutical company on a 12-month contract. The role focuses on supporting the Quality Management System and ensuring GMP/GDP compliance across the EU.

You will work with Affiliate Management, Market Quality, and Regulatory teams to drive CAPAs, deviations, change controls, and product release readiness, while maintaining training matrices and supporting regulatory inspections.