Deviations Consultant

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.Deviations Consultant - Responsibilities:Lead and manage the deviation lifecycle: identification, classification, investigation, root cause analysis, corrective/preventive actions (CAPAs), and closure in line with GDP requirementsDevelop and review deviation policies, procedures, and work instructions to reflect best practices and regulatory expectationsConduct risk assessments for deviations, ensuring proper impact evaluation on product quality, distribution, and patient safetyProvide subject-matter-expert support during internal/external audits, inspections, and regulatory reviews related to deviation and CAPA systemsMonitor trends in deviations, generate reports and KPIs, present findings, and drive continuous improvement of deviation handling practicesCollaborate with cross-functional stakeholders including Quality, Operations, Regulatory, and Safety to ensure deviation actions are feasible, timely, and effectiveDeviations Consultant - Requirements:Proven experience in a deviation / CAPA specialist or consultant role within healthcare logistics or pharmaceutical distribution under GDP / GMP environmentsStrong understanding of GDP regulations, MHRA expectations, and other applicable UK/EU regulatory guidelines for pharmaceutical distributionExperience performing root cause analysis using recognised methods (e.g., 5 Whys, Ishikawa diagrams) and managing CAPA systems through resolutionExcellent documentation and communication skills; able to produce clear reports, SOPs, and update procedures as requiredAbility to work hands-on and onsite as required; site audits and investigations occasionally necessaryMust be based in the UK and eligible to work under contract termsMantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at +44 (0)20 3854 7700.

Created: 2025-09-13