Description Key Roles & Responsibilities:- Supporting key quality system elements, including activities relating to QMS monitoring, Qualification of Vendors, Audits (Self-Inspections, Vendor Audits, Customer Audits). Support updates to regulatory agency registrations as applicable. Support tracking of site compliance commitments and follow up actions. Working with the wider site functions to drive down out of compliance events and implement quality improvements Support and track regulatory findings and trends that may lead into a focus of regulatory inspections Support review of procedures and other QMS related documentation according to internal guidelines and UK/EU/US/ICH and other region specific guidance. Lead Quality Management Review meetings highlighting GxP areas of concern and working to support and track actions that are to be taken. Support quality related investigations, assist in the development and approval of effective CAPA in order to resolve product, audit and customer issues. Support effective pre-audit preparation and post audit follow up of customer audits and regulatory inspections. Escalate any significant breach of quality or regulatory compliance to Quality Management. Maintain productive working relationships with other site personnel and stakeholders. Key Competencies:- Attention to detail Problem solving skills Excellent communication skills Proficient in using Microsoft Office based applications- PowerPoint, MS Excel, MS Word, etc. Qualifications RELEVANT EXPERIENCE: At least 2 years’ experience within Quality Assurance working to GMP. Experience of performing self-inspections or audits of 3rd party suppliers (GMP material manufacturing /testing laboratories, API or Drug Product manufacturing facilities Experience of working within a Quality Management System e.g. completing or reviewing QMS documentation (SOPs/Deviations /Investigations /CAPA) Certified Auditor Training Experience working on activities associated with supplier/vendor/material approval Experience of supporting activities relating to audits and/or regulatory inspections.