Senior Quality Specialist - Risk ManagementRK3939Contract - 12 monthsCorkWe're currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.Duties:Execution of the Quality Risk Management (QRM) & Site Quality Risk Register (SQRR) processes ensuring effective governance, communication and management systems are in place and maintained.Execution of the Quality Internal & External Audit/Inspections preparation and management processes for the Site (including follow up on audit action completion, associated CAPA's, and NC Quality approval).Participate in Site risk assessments.Execute site and quality driven improvement projects as per the site Risk Register e.g. but not limited to,Supplier Qualifications.Reclassification of plant areas.Site Data Integrity ProgramManages projects effectively to meet strict timelines and achieve established milestones with regular updates to Quality and Site Leadership Teams.Quality Review and Approval of SOPs, Work Instructions and forms from other departments and periodic reviews.Responsible for Gemba Walkdowns & Inspection Readiness Walkdowns from a Quality perspective.Quality review and approval of quality non-conformance (NC) records. Quality point of contact for attendance at Root Cause Analysis meetings.Initiation and ownership of Quality non-conformance records.Quality assessor, reviewer and approval of quality non-conformance (NC) records.Experience and Education:Third level Degree in a science or pharmaceutical discipline.3 to 5 years' experience in a quality or compliance role within the biological and/or pharmaceutical industry.Demonstrated knowledge and application of industry regulations including those of FDA, HPRA, EMEA and other authorities.Experience with risk management projects, data integrity and driving improvements is a mustIf interested in this posting please feel free to contact Rachel Kent on or for further information.