# Quality Validation and CSV Senior Specialist

**Company**: GSK
**Location**: Barnard Castle, County Durham
**Work arrangement**: onsite
**Experience**: senior
**Job type**: full-time
**Category**: Operations
**Industry**: Healthcare

**Apply**: https://gsk.wd5.myworkdayjobs.com/en-US/GSKCareers/job/UK---County-Durham---Barnard-Castle/Quality-Validation-and-CSV-Senior-Specialist_447405-1?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_58052804-3a7

## Description

We are seeking a Quality Validation and CSV Senior Specialist to lead and deliver Quality Assurance, New Product Introduction (NPI), Validation and Computerised Systems Validation (CSV) activities across projects and operations. The successful candidate will work closely with project teams, engineering, IT and manufacturing to ensure systems, processes and products are implemented and maintained in a compliant and effective manner.

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.

- Drive improvements to validation processes, templates and tools to increase efficiency and compliance.

Requirements:

- 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.

This role offers significant opportunities for professional growth, the chance to make a measurable impact on patient supply, and the opportunity to help unite science, technology and talent to get ahead of disease together.

## Skills

### Required
- GxP Regulations
- Quality Assurance (QA)
- Validation Processes
- Technical Writing
- Risk Awareness
- Project Management
- Lean Management
- Influencing Without Authority
- Digital Fluency
- Detail-Oriented
- Data Integrity

### Nice to have
- Advanced degree in science, engineering or a related technical field
- Experience applying GAMP principles and data integrity requirements
- Proven experience supporting regulatory inspections and interactions
- Track record delivering validation for MES, automation or laboratory systems
- Strong risk assessment skills and experience documenting risk-based decisions
- Experience driving continuous improvement and validation tooling

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Source: [Apply at gsk.wd5.myworkdayjobs.com](https://gsk.wd5.myworkdayjobs.com/en-US/GSKCareers/job/UK---County-Durham---Barnard-Castle/Quality-Validation-and-CSV-Senior-Specialist_447405-1?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)