Senior Quality Validation & CSV Specialist

GSK; Fir Tree; On-site; GBP 65,000 - 85,000; Full time

Job summary

GSK Barnard Castle seeks a Quality Validation and CSV Senior Specialist to lead validation activities for processes, facilities, equipment and simple computerised systems, with oversight of NPI and batch documentation. You will collaborate with cross-functional teams to ensure compliant, efficient validation and risk-based decision making.

The role focuses on risk-based QA across projects, supporting inspections and continuous improvement, with opportunities for growth in a state-of-the-art

Qualifications

• Degree in a scientific, technical or engineering discipline, or equivalent relevant experience.
• Practical experience in validation or quality assurance in a regulated environment.
• Experience in computerised system validation or lifecycle activities for IT/automation systems.
• Working knowledge of GMP and quality management systems.
• Experience producing and reviewing validation and batch release documentation.
• Clear communication skills and ability to work effectively with cross-functional teams.

Responsibilities

• Plan, lead and execute validation activities for processes, facilities, equipment and simple computerised systems.
• Provide quality oversight for new product introduction, technical transfers and batch documentation.
• Prepare and maintain validation protocols, test scripts, final reports and supporting evidence.
• Make timely, risk-based quality decisions and communicate rationale to stakeholders.
• Support inspections, prepare evidence and close agreed actions.
• Drive improvements to validation processes, templates and tools to increase efficiency and compliance.

Skills

Quality Assurance

Validation

CSV

GMP

Documentation

Cross-functional collaboration

Education

Degree in science/engineering

Advanced degree (preferred)

Tools

GAMP principles

MES/automation systems

IT/automation validation

Job description

GSK Barnard Castle seeks a Quality Validation and CSV Senior Specialist to lead validation activities for processes, facilities, equipment and simple computerised systems, with oversight of NPI and batch documentation. You will collaborate with cross-functional teams to ensure compliant, efficient validation and risk-based decision making.

The role focuses on risk-based QA across projects, supporting inspections and continuous improvement, with opportunities for growth in a state-of-the-art