Senior Quality Validation & CSV Lead – Onsite UK

GSK; Barnard Castle; On-site; GBP 70,000 - 90,000; Full time

Job summary

GSK Barnard Castle is seeking a hands-on Quality Assurance and Validation lead to drive NPI, validation and CSV activities across projects and operations onsite. You will collaborate with engineering, IT and manufacturing to ensure compliant, effective systems and processes, delivering on time.

The role offers exposure to industry 4.0 technologies, risk-based decision making, and opportunities to influence continuous improvement in a fast-paced pharmaceutical environment.

Qualifications

• Degree in a scientific, technical or engineering discipline or equivalent.
• Practical validation or QA experience in a regulated environment.
• Experience with 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 and cross-functional collaboration.

Responsibilities

• Plan, lead and execute validation activities for processes, facilities, equipment and simple computerised systems.
• Provide quality oversight for new product introduction, tech 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 actions.
• Drive improvements to validation processes, templates and tools to increase efficiency and compliance.

Skills

Data Integrity

Detail-Oriented

Digital Fluency

GxP Regulations

Influencing Without Authority

Lean Management

Problem Solving

Project Management

Quality Assurance (QA)

Risk Awareness

Technical Writing

Validation Processes

Education

Degree in a scientific, technical or engineering discipline

Job description

GSK Barnard Castle is seeking a hands-on Quality Assurance and Validation lead to drive NPI, validation and CSV activities across projects and operations onsite. You will collaborate with engineering, IT and manufacturing to ensure compliant, effective systems and processes, delivering on time.

The role offers exposure to industry 4.0 technologies, risk-based decision making, and opportunities to influence continuous improvement in a fast-paced pharmaceutical environment.