CSV Coordinator

Proactive.IT Appointments Limited; Luton; Hybrid; GBP 35,000 - 45,000; Full time

Job summary

A leading global distribution organization is looking for a motivated CSV Coordinator to support IT and Quality teams in compliance and validation efforts. This role involves managing system validation activities, coordinating change management processes, and ensuring adherence to GxP standards. Strong knowledge of documentation practices and excellent communication skills are essential. The position offers a contract for 3-6 months with remote work and occasional site visits.

Qualifications

• 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.
• Excellent written and verbal communication skills.
• Ability to work under pressure and meet tight deadlines.

Responsibilities

• Act as Principal CRF Administrator for IT systems change management.
• Coordinate weekly Change Advisory Board (CAB) meetings.
• Maintain change request logs and prepare reports.
• Manage emergency change requests and related documentation.
• Support validation testing and act as Test Manager Designee.
• Develop and maintain IT/IS procedures.

Skills

GxP Good Documentation Practices

Documentation control

Microsoft Office Suite

Communication skills

ERP systems knowledge

Adaptability

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Microsoft Outlook

Microsoft Teams

AI tools (e.g., Copilot)

Job description

11414HS
£35k – 45k per year + pro rata

CSV Coordinator

3-6 month FTC – Remote with occasional site visits

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.

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