Job Description

QAagency is delighted to be working with a global leader in in-vitro diagnostics, supporting their UK operations based in Dartford, Kent. As part of their growing quality and compliance team, they are looking to recruit a Quality Assurance Validation Specialist to manage and drive validation activities across production, systems, and product development.

As the Quality Assurance Validation Specialist, you will coordinate the site validation programme and lead validation planning and execution in line with regulatory standards. You'll support technology transfers and new product development, review and approve validation documentation, and ensure processes meet ISO 13485 and GMP requirements. This is a full-time, on-site role (37.5 hours/week) with no hybrid working.

Own and manage the Site Validation Master Plan (sVMP) and project-specific VMPs. Lead validation activities for equipment, systems, and non-product software. Support audits and regulatory inspections with up-to-date validation documentation. Assess the impact of changes and provide training within your areas of expertise.
Key Requirements

Minimum 4 years' experience in validation, manufacturing, quality, or engineering. Familiarity with ISO 13485, risk management, and compliance in a regulated environment. Strong problem-solving and data analysis skills. Experience with IVD or pharmaceutical/chemical industries (preferred).
This position offers a salary of 37,500 along with a strong benefits package, including:

Private medical insurance for the individual (option to add family) Pension up to 12% employer contribution (when employee contributes 6%) Group life assurance and income protection 25 days annual leave, plus bank holidays and options to buy or carry over up to 5 days Free on-site parking Online retail discounts Convenient location, 10-minute walk from Dartford train station
Job Types: Full-time, Permanent

Pay: 37,500.00 per year

Benefits:

Company events Company pension Free or subsidised travel Free parking Health & wellbeing programme Life insurance On-site parking Private medical insurance
Schedule:

Monday to Friday
Experience:

Good Manufacturing Practice (GMP): 3 years (required) ISO 13485: 3 years (required) compliance in a regulated environment: 2 years (preferred)
Work Location: In person

Application deadline: 09/05/2025
Reference ID: DT19