IT Test & Validation Analyst

Job Overview

Norbrook is recruiting for an IT Test and Validation Analyst to coordinate and perform verification and test activities on IT Infrastructure and computer system applications to achieve compliance with business and regulatory standards. You will ensure the qualified or validated systems/infrastructure is maintained and audit-ready throughout their lifecycle

Main Activities/Tasks

• Lead and Conduct evaluations and risk assessments of systems, developing and managing a risk-based verification and testing strategy 
• Perform risk assessments to identify and mitigate potential compliance gaps.
• Develop test plans, protocols and test scripts in accordance with regulatory guidelines and company Standard Operating Procedures.
• Coordinate and execute verification and testing activities.
• Review test outcomes and compile test reports.
• Document issues identified during testing. 
• Review and approve system documentation and validation deliverables ensuring adherence to GAMP 5 principles.
• Maintain traceability matrices to ensure complete requirement coverage.
• Manage validation lifecycle documentation,
• Investigate and document deviations and ensure corrective/preventive actions are implemented
• Support periodic reviews, revalidation activities, and audit readiness.
• Stay current with evolving regulations and best practices - identifying improvement opportunities within the IT Quality Management System (QMS). 
• Prepare for audits and regulatory inspections, providing timely responses to observations and inquiries. 
• Foster collaboration within the team, QA and business, proactively identifying issues and suggesting solutions to ensure smooth project progress. 
• Perform all duties in accordance with applicable GxP regulations (GMP, GLP, GCP, GPvP), utilizing relevant SOPs, methods, and tools. 
• Adherence to company quality standards

Essential Criteria:

• Level 5 qualification (UK) in Computer Science, Information Technology, Life Sciences, or a related field, or equivalent professional experience.
• Meticulous attention to detail with strong documentation and report-writing skills.
• Excellent interpersonal skills with confidence in engaging and supporting end-users.
• Proven ability to work independently as well as collaboratively within a team, consistently meeting agreed service levels.
• Team player with effective problem-solving skills and proactive in identifying issues early and recommending practical solutions.
• Proficient in Microsoft Office (Word and Excel).

Desirable Criteria:

• 2+ years’ experience in computer system validation or related quality/compliance roles within regulated industries (pharmaceutical, biotechnology, or medical devices).
• Solid understanding of GxP compliance, including FDA 21 CFR Part 11, Annex 11, and related guidelines.
• Familiar with risk management principles, compliance frameworks, and associated tools.
• Practical experience with Enterprise Resource Planning (ERP) systems and/or Quality Management Systems (QMS).
• Knowledge of GAMP 5 and risk-based validation approaches, including Computer Software Assurance (CSA).
• Proven experience supporting or conducting audits.
• Understanding of data integrity principles, including audit trail review practices.

Duration: Permanent
Location: Newry

Additional Information:

• Applicants should be able to provide proof of their right to work in the UK. Applicants who are unable to provide this proof will not be considered.
• We are unable to sponsor or take over sponsorship of a Visa at this time.

Benefits:

• Free life assurance
• Company pension scheme
• Healthcare cash plan
• 32 days annual leave
• Wedding leave
• Company sick pay
• Employee well-being initiatives
• Employee assistance programme
• On-site free parking
• Subsidised canteen facilities
• Employee perks scheme
• Employee recognition scheme
• Career development opportunities