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 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
Deviations Consultant - 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
Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at +44 (0)20 3854 7700.