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 focus on innovation.
- Benefits: Enjoy 32 days annual leave, healthcare cash plan, and career development opportunities.
- Other info: Dynamic role with opportunities for growth in a supportive environment.
- 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.
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 TLNT1_NI 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, employees are empowered to thrive in their roles while contributing to a company committed to compliance and quality in the pharmaceutical industry.
StudySmarter Expert Advice🤫
We think this is how you could land IT Test & Validation Analyst TLNT1_NI
✨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 put in a good word for you.
✨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 project that highlights your experience with compliance and validation processes. This can really set you apart from other candidates.
✨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 TLNT1_NI
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 and skills that match the job description, especially your attention to detail and documentation skills.
Showcase Your Experience:If you've got experience in computer system validation or compliance roles, flaunt it! Mention specific projects or tasks where you’ve successfully managed risk assessments or developed test plans.
Be Clear and Concise:When writing your application, keep it clear and concise. Use bullet points for easy reading and make sure to proofread for any typos or errors. We love a well-organised application!
Apply Through Our Website:Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. 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 Annex 11. 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.
✨Showcase Your Documentation Skills
Since meticulous documentation is key for this position, prepare examples of your past work where you’ve created test plans, protocols, or reports. Bring these along to the interview to demonstrate your attention to detail and strong report-writing skills.
✨Prepare for Risk Assessment Questions
Expect questions about risk assessments and how you would identify and mitigate compliance gaps. Think of specific scenarios from your experience where you successfully managed risks and be ready to share those stories.
✨Engage with the Team Spirit
This role requires collaboration, so be prepared to discuss how you’ve worked effectively within a team. Share examples of how you’ve proactively identified issues and suggested solutions, highlighting your problem-solving skills and teamwork.
