At a Glance
- Tasks: Coordinate and perform testing on IT systems to ensure compliance with standards.
- Company: Join Norbrook, a leader in the pharmaceutical industry with a focus on quality.
- Benefits: Enjoy 32 days annual leave, healthcare cash plan, and career development opportunities.
- Other info: Dynamic team environment with excellent growth potential and employee recognition.
- Why this job: Make a real impact by ensuring IT systems meet regulatory standards.
- Qualifications: Level 5 qualification in IT or related field; attention to detail is key.
The predicted salary is between 30000 - 40000 £ per year.
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 in Newry employer: Norbrook
Norbrook is an exceptional employer located in Newry, offering a supportive work culture that prioritises employee well-being and professional growth. With comprehensive benefits such as a company pension scheme, healthcare cash plan, and generous annual leave, employees are encouraged to thrive both personally and professionally. The company fosters collaboration and innovation, providing ample opportunities for career development in a dynamic environment focused on compliance and quality assurance.
StudySmarter Expert Advice🤫
We think this is how you could land IT Test & Validation Analyst in Newry
✨Tip Number 1
Network like a pro! Reach out to folks in the industry, attend meetups, and connect on LinkedIn. You never know who might have the inside scoop on job openings or can refer you directly.
✨Tip Number 2
Prepare for interviews by practising common questions and scenarios related to IT Test & Validation. We recommend doing mock interviews with friends or using online platforms to boost your confidence.
✨Tip Number 3
Showcase your skills! Create a portfolio or a GitHub repository with examples of your work, especially if you've developed test plans or protocols. This gives potential employers a tangible look at what you can do.
✨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 are proactive about their job search!
We think you need these skills to ace IT Test & Validation Analyst in Newry
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the IT Test & Validation Analyst role. Highlight your relevant experience, especially in compliance and validation, and don’t forget to mention any specific tools or methodologies you’ve used that align with the job description.
Show Off Your Attention to Detail:Since this role requires meticulous attention to detail, use your application to showcase this skill. Include examples of how you've successfully documented processes or managed compliance in previous roles. We love seeing candidates who can demonstrate their thoroughness!
Be Clear and Concise:When writing your application, keep it clear and concise. Use bullet points where possible to make your achievements stand out. We appreciate straightforward communication, so avoid jargon unless it’s relevant to the role.
Apply Through Our Website:Don’t forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re keen on joining our team at StudySmarter!
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 GAMP 5 principles. Being able to discuss these in detail will show that you understand the compliance landscape and are ready to tackle the challenges of the role.
✨Prepare Your Test Plans
Before the interview, think about how you would develop test plans and protocols. Be ready to share examples of your past experiences with risk assessments and how you’ve managed validation lifecycle documentation. This will demonstrate your hands-on experience and strategic thinking.
✨Show Off Your Team Spirit
Collaboration is key in this role, so be prepared to talk about how you've worked with teams in the past. Share specific examples where you identified issues early and suggested practical solutions. This will highlight your proactive approach and ability to foster teamwork.
✨Be Audit-Ready
Since audit readiness is a big part of the job, think about how you’ve prepared for audits in previous roles. Discuss your experience with documenting issues and implementing corrective actions. This will show that you’re not just familiar with the process but also committed to maintaining high standards.
