Senior CSV & Quality Validation Specialist

GSK; Barnard Castle; On-site; GBP 70,000 - 100,000; Full time

Job summary

GSK Barnard Castle is seeking a Quality Validation and CSV Senior Specialist to lead QA, NPI, CSV activities across projects and operations, collaborating with engineering, IT and manufacturing to ensure compliant systems and processes.

You will plan, execute and document risk-based validation activities, provide practical problem-solving expertise, and support teams to achieve project and operational objectives on time.

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 good manufacturing practice (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, documented, risk-based quality decisions and clearly communicate rationale to stakeholders.
• Support internal and external inspections, prepare evidence and close agreed actions.

Skills

Quality Assurance

CSV

NPI

GMP/GxP

Documentation

Risk Management

Project Management

Problem Solving

Communication

Technical Writing

Validation Processes

Education

Degree in scientific/engineering discipline

Advanced degree (preferred)

Job description

GSK Barnard Castle is seeking a Quality Validation and CSV Senior Specialist to lead QA, NPI, CSV activities across projects and operations, collaborating with engineering, IT and manufacturing to ensure compliant systems and processes.

You will plan, execute and document risk-based validation activities, provide practical problem-solving expertise, and support teams to achieve project and operational objectives on time.