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Mantell Associates is partnered with a leading healthcare logistics company, who is seeking an experienced Deviations Consultant to support its GDP operations. This contract role will play a key part in quality assurance, ensuring that deviation management, root cause analysis, and compliance are rigorously maintained.
Job Responsibility:
Lead and manage the deviation lifecycle: identification, classification, investigation, root cause analysis, corrective/preventive actions (CAPAs), and closure in line with GDP requirements
Develop and review deviation policies, procedures, and work instructions to reflect best practices and regulatory expectations
Conduct risk assessments for deviations, ensuring proper impact evaluation on product quality, distribution, and patient safety
Provide subject-matter-expert support during internal/external audits, inspections, and regulatory reviews related to deviation and CAPA systems
Monitor trends in deviations, generate reports and KPIs, present findings, and drive continuous improvement of deviation handling practices
Collaborate with cross-functional stakeholders including Quality, Operations, Regulatory, and Safety to ensure deviation actions are feasible, timely, and effective
Requirements:
Proven experience in a deviation / CAPA specialist or consultant role within healthcare logistics or pharmaceutical distribution under GDP / GMP environments
Strong understanding of GDP regulations, MHRA expectations, and other applicable UK/EU regulatory guidelines for pharmaceutical distribution
Experience performing root cause analysis using recognised methods (e.g., 5 Whys, Ishikawa diagrams) and managing CAPA systems through resolution
Excellent documentation and communication skills
able to produce clear reports, SOPs, and update procedures as required
Ability to work hands-on and onsite as required
site audits and investigations occasionally necessary
Must be based in the UK and eligible to work under contract terms
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