QA Validation Specialist

QA Validation Specialist

The Role

This role is key to maintaining the validated state of critical systems while ensuring full compliance with regulatory requirements, internal policies, and industry best practices.

• Review and approve qualification and requalification protocols (IQ, OQ, PQ) for equipment, systems, facilities, laboratories, and utilities.
• Support execution of qualification activities, including walkthroughs, drawing verification, and system assessments.
• Generate, execute, and maintain project validation plans and Validation Master Plans.
• Provide QA oversight and regulatory guidance for qualification, validation, CSV, and data integrity activities.
• Review and approve SOPs, drawings, reports, and supporting documentation related to validation.
• Support laboratory equipment qualification, including protocol and report approval.
• Lead investigations related to validation or qualification deviations and define appropriate corrective actions.
• Act as a primary QA interface with Engineering, Manufacturing, and external vendors, including participation in FATs where required.
• Maintain audit readiness for validation activities and support regulatory inspections.
• Participate in risk assessments, investigations, and studies that may impact the qualified state of systems.

• Bachelor's degree in a science or engineering discipline.
• Minimum of 5 years' experience in a QA Validation role within the pharmaceutical industry.
• Strong knowledge of EU and FDA regulations related to qualification, validation, computerised systems, data integrity, and GDP.
• Excellent protocol and report writing skills.
• Strong problem-solving and troubleshooting capability within a regulated environment.
• Effective communicator with strong organisational and stakeholder management skills.
• Ability to prioritise, direct work, and meet deadlines in a dynamic setting.