QA Validation Specialist
The Role
Our client is seeking an experienced QA Validation Specialist to support qualification and validation activities across equipment, computerised systems, facilities, laboratories, and utilities at a regulated pharmaceutical manufacturing site. 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.
Responsibilities
- 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.
Requirements
- 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.
