Quality Specialist (Risk Management)Department:QualityReporting to:Quality Systems LeadLocation:CorkVacancy:1Industry Requirement:Pharmaceutical background essentialMain Duties & ResponsibilitiesQuality Risk ManagementExecute the Quality Risk Management (QRM) and Site Quality Risk Register (SQRR) processes.Maintain effective governance, communication, and management systems.Audit & Inspection ReadinessSupport preparation and management of internal and external audits/inspections.Follow up on audit actions, CAPAs, and Quality approval of non-conformance (NC) records.Risk & Improvement ActivitiesParticipate in site risk assessments.Execute site and quality-driven improvement projects aligned to the Risk Register, including but not limited to:Supplier QualificationReclassification of plant areasSite Data Integrity ProgramProject ManagementManage projects to meet strict timelines and achieve established milestones.Provide regular progress updates to Quality and Site Leadership Teams.Quality Systems ResponsibilitiesPerform Quality review and approval of SOPs, Work Instructions, and forms (including periodic reviews).Conduct Gemba walkdowns and Inspection Readiness walkdowns from a Quality perspective.Review and approve NC records and participate in Root Cause Analysis meetings.Initiate and own Quality non-conformance records.Serve as Quality assessor, reviewer, and approver for NC records.Key Experience RequiredDemonstrated experience with data integrity as a QA Specialist.Proven experience in risk management projects and driving continuous improvements.Key Skills & CompetenciesBuilds strong, productive relationships.Collaborates effectively with teams and individuals.Actively seeks opportunities for professional growth.Applies best practices to improve business operations.Maintains accountability for compliant and flawless execution.Makes decisions that deliver customer value.Demonstrates adaptability and effective change management.Always acts with integrity and aligns with the Credo.Education & Experience RequirementsThird-level degree in a scientific or pharmaceutical discipline.3–5 years' experience in a quality or compliance role within the biological and/or pharmaceutical industry.Solid understanding of regulatory requirements including FDA, HPRA, EMEA, and other relevant authorities.