Senior Quality Validation & CSV Specialist

Biopharma Careers; Barnard Castle; On-site; GBP 65,000 - 90,000; Full time

Job summary

GSK Barnard Castle is seeking a Quality Validation and CSV Senior Specialist to lead validation, CSV and QA activities across projects and operations. You will partner with engineering, IT and manufacturing to ensure compliant, effective systems and processes are implemented on time.

This full-time onsite role offers exposure to state-of-the-art, industry 4.0 manufacturing, risk-based decision making, and opportunities to influence inspection readiness and continuous improvement.

Qualifications

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

Responsibilities

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

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

Bachelor's or equivalent in scientific/engineering

Advanced degree in science/engineering

Job description

GSK Barnard Castle is seeking a Quality Validation and CSV Senior Specialist to lead validation, CSV and QA activities across projects and operations. You will partner with engineering, IT and manufacturing to ensure compliant, effective systems and processes are implemented on time.

This full-time onsite role offers exposure to state-of-the-art, industry 4.0 manufacturing, risk-based decision making, and opportunities to influence inspection readiness and continuous improvement.