At a Glance
- Tasks: Lead testing and validation of IT systems to ensure compliance and quality.
- Company: Join Norbrook, a leader in the pharmaceutical industry with a commitment to innovation.
- Benefits: Enjoy 32 days annual leave, healthcare cash plan, and career development opportunities.
- Other info: Dynamic work environment with excellent growth potential and employee recognition initiatives.
- Why this job: Make a real impact by ensuring IT systems meet regulatory standards and improve quality.
- Qualifications: Level 5 qualification in IT or related field; attention to detail and teamwork skills required.
The predicted salary is between 30000 - 40000 £ per year.
Job ref: ITTVA
Job type: Permanent
Location: Newry
Closing date: Wednesday 10 Jun
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.
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
To Apply
Please forward your CV via the APPLY Now button below.
IT Test & Validation Analyst employer: Norbrook
Norbrook is an exceptional employer located in Newry, offering a supportive work culture that prioritises employee well-being and professional growth. With benefits such as a comprehensive healthcare cash plan, generous annual leave, and career development opportunities, Norbrook fosters an environment where employees can thrive while contributing to meaningful projects in the IT sector. Join us to be part of a team that values collaboration, innovation, and compliance in a dynamic industry.
StudySmarter Expert Advice🤫
We think this is how you could land IT Test & Validation Analyst
✨Tip Number 1
Get your networking game on! Reach out to folks in the industry, especially those who work at Norbrook or similar companies. A friendly chat can sometimes lead to insider info about job openings or even a referral.
✨Tip Number 2
Prepare for interviews like a pro! Research common questions for IT Test & Validation Analyst roles and practice your answers. We recommend using the STAR method (Situation, Task, Action, Result) to structure your responses.
✨Tip Number 3
Show off your skills! If you have any relevant projects or experiences, be ready to discuss them in detail. Bring examples of how you've tackled compliance issues or improved testing processes in the past.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, we love seeing candidates who take that extra step to connect with us directly.
We think you need these skills to ace IT Test & Validation Analyst
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the IT Test & Validation Analyst role. Highlight relevant experience and skills that match the job description, especially around compliance and testing activities.
Showcase Your Attention to Detail:Since this role requires meticulous attention to detail, include examples in your application that demonstrate how you've successfully managed documentation and reports in previous roles.
Be Proactive in Your Application:Don’t just list your qualifications; show us how you’ve proactively identified issues and implemented solutions in past projects. This will help us see your problem-solving skills in action.
Apply Through Our Website:We encourage you to apply through our website for a smoother process. It helps us keep track of your application and ensures you don’t miss any important updates!
How to prepare for a job interview at Norbrook
✨Know Your GxP Regulations
Make sure you brush up on GxP regulations, especially FDA 21 CFR Part 11 and Annex 11. Being able to discuss these in detail will show that you understand the compliance landscape and can navigate it effectively.
✨Demonstrate Your Attention to Detail
Since this role requires meticulous documentation and report-writing skills, prepare examples from your past experiences where your attention to detail made a difference. Bring along any relevant reports or documents to showcase your work.
✨Prepare for Risk Management Questions
Expect questions about risk assessments and validation strategies. Think of specific instances where you identified compliance gaps and how you addressed them. This will highlight your proactive problem-solving skills.
✨Showcase Your Team Collaboration Skills
This position involves working closely with various teams. Be ready to share examples of how you've successfully collaborated in the past, particularly in high-pressure situations. Highlight your interpersonal skills and ability to foster teamwork.
