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For Companies At a Glance
- Tasks: Coordinate IT system validation and change management for a global distribution leader.
- Company: Join a top global organisation delivering critical products worldwide.
- Benefits: Competitive salary, remote work, and opportunities for professional growth.
- Why this job: Make an impact in compliance and quality assurance while working remotely.
- Qualifications: Knowledge of GxP practices and strong communication skills required.
- Other info: Dynamic role with potential for career advancement in a supportive environment.
The predicted salary is between 28000 - 36000 £ per year.
Join a leading global distribution organisation at the forefront of delivering critical products and services worldwide. We are seeking a motivated and detail-oriented CSV Coordinator to support our IT and Quality teams in ensuring compliance, system validation, and effective change management across our operations.
Role Overview
The CSV Coordinator will act as the principal administrator for Computer System Validation (CSV) activities and IT Change Management processes, ensuring all IT implementation, system decommissioning, and operational changes are conducted in compliance with GxP standards. This role will also support the Compliance & Validation Manager in validation testing, training, and promoting awareness of quality standards within IT services.
Key Duties and Responsibilities
- Act as Principal CRF Administrator and Compliance Coordinator for global and local IT systems change management, reporting regularly to the Compliance & Validation Manager.
- Coordinate weekly Change Advisory Board (CAB) meetings for global and local IT application change requests.
- Maintain change request logs and prepare statistics and analysis reports.
- Efficiently manage emergency change requests and associated documentation.
- Support the Compliance & Validation Manager in validation testing, acting as Test Manager Designee for test script reviews.
- Administer the CSV and Computer System Assurance (CSA) processes, ensuring accurate maintenance of validation artifacts and evidence for all new and existing systems.
- Develop, document, and maintain IT/IS procedures, particularly related to Change Management and Risk Management.
- Support the creation and delivery of training plans for IT personnel, ensuring compliance with standard training procedures.
- Assist in implementing automated Change Control systems and perform acceptance testing of these systems.
- Promote awareness of the Quality Management System (QMS) and GxP Good Documentation Practices across the business and with IT service providers.
Knowledge, Skills & Experience
- Strong knowledge of GxP Good Documentation Practices.
- Understanding of the Validation V Model (GAMP5).
- Knowledge of FDA regulatory requirements for information systems (21 CFR Part 11 and Part 820).
- Experience with ERP systems or foundational ERP knowledge.
- Clear understanding and experience of documentation control.
- Excellent written and verbal communication skills with the ability to maintain clear procedures.
- Proven ability to liaise with stakeholders at all levels across the organisation.
- Ability to work under pressure, meet tight deadlines, and adapt to changing priorities.
- Proficient in Microsoft Word, Excel, PowerPoint, Outlook, Teams, and AI tools such as Copilot.
- Ability to work independently, manage own workload effectively, and collaborate as part of a team.
Due to the volume of applications received for positions, it will not be possible to respond to all applications and only applicants who are considered suitable for interview will be contacted. Proactive Appointments Limited operates as an employment agency and employment business and is an equal opportunities organisation. We take our obligations to protect your personal data very seriously. Any information provided to us will be processed as detailed in our Privacy Notice, a copy of which can be found on our website.
CSV Coordinator – 11414HS in Luton employer: Proactive.IT Appointments Limited
Contact Detail:
Proactive.IT Appointments Limited Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land CSV Coordinator – 11414HS in Luton
✨Tip Number 1
Get to know the company inside out! Research their values, mission, and recent projects. This will help you tailor your conversations and show that you're genuinely interested in being part of their team.
✨Tip Number 2
Network like a pro! Reach out to current or former employees on LinkedIn. Ask them about their experiences and any tips they might have for landing the CSV Coordinator role. You never know who might give you a leg up!
✨Tip Number 3
Prepare for the interview by practising common questions related to GxP standards and validation processes. We recommend doing mock interviews with friends or using online resources to boost your confidence.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, it shows you’re serious about the opportunity and ready to take the next step in your career.
We think you need these skills to ace CSV Coordinator – 11414HS in Luton
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the CSV Coordinator role. Highlight your experience with GxP Good Documentation Practices and any relevant IT change management skills. We want to see how your background aligns with what we're looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about this role and how you can contribute to our team. Keep it concise but impactful – we love a good story that connects your experience to our needs.
Show Off Your Communication Skills: Since excellent written communication is key for this role, make sure your application is clear and free of errors. We appreciate attention to detail, so take the time to proofread and ensure everything flows nicely!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it gives you a chance to explore more about us and what we do!
How to prepare for a job interview at Proactive.IT Appointments Limited
✨Know Your GxP Standards
Make sure you brush up on GxP Good Documentation Practices and the Validation V Model (GAMP5). Being able to discuss these concepts confidently will show that you understand the compliance landscape and can navigate it effectively.
✨Showcase Your Communication Skills
Since the role involves liaising with stakeholders at all levels, practice articulating your thoughts clearly. Prepare examples of how you've communicated complex information in the past, especially in high-pressure situations.
✨Familiarise Yourself with Change Management
Understand the ins and outs of IT Change Management processes. Be ready to discuss how you've managed change requests or contributed to similar processes in previous roles. This will demonstrate your practical experience and readiness for the CSV Coordinator position.
✨Prepare for Scenario-Based Questions
Expect questions that ask how you would handle specific situations, like emergency change requests or validation testing. Think through potential scenarios and your approach to them, as this will highlight your problem-solving skills and ability to work under pressure.
