Quality Complaint&Recall Administrator, Dublin

Company description: Company description: At Vital Healthcare we provide the medical devices, medicines and diagnostic products that help healthcare professionals and patients across the Island of Ireland and the UK manage illness and restore health. But what we deliver is more than simply the mechanics of treatment. We seek to be the best service provider of Medical Devices, Medicines and Services to the healthcare sector. Our brands in Ireland include Fannin&Medisource. With the heritage of care giving dating back to 1829 we have the track record to support our claims. We deliver confidence in our ability, we have the financial strength to sustain and develop our business which is underpinned by our dedicated workforce. Fannin is continually expanding its product portfolio in both the medical and pharma sectors both organically and through acquisition. We have an active partnering strategy and are always seeking partnership opportunities in the fields of pharmaceuticals, medical devices and diagnostic products. Whether youre a manufacturer seeking a distribution partner for the UK or the Irish market, a healthcare professional looking to commercialise an innovative concept, or a start-up in the med-tech sector, Fannin has expertise to deliver your products. In recent years, we have made a number of acquisitions in the pharma and medical devices sectors which provide us with the perfect platform for growth in our existing markets and new growth areas. All of these relationships mean that we can bring you more more products, more know-how and more ways to care for life. For information about job opportunities at Fannin and across the wider Vital Healthcare business, please our careers site. Job description: Quality Complaint&Recall Administrator TECHNICAL DIVISION Job title: Quality Complaint and Recall Administrator Location: Fannin House, Leopardstown, D18 Reporting to: Quality&Regulatory Lead Medical Devices Summary The Quality Complaints&Recall Administrator is responsible for the coordination and administration of complaint handling, product recalls and Field Safety Corrective Actions (FSCAs) within a regulated pharmaceutical and medical device distribution environment. The role supports compliance with GDP, GMP, MDR and IVDR requirements through effective investigation, documentation, reporting and follow-up of quality activities, while supporting Quality Management System processes and maintaining audit readiness. Principal Duties and Responsibilities: Administration and coordination of the end-to-end complaint handling process Coordination of product recalls and Field Safety Corrective Actions (FSCAs) Ensure compliance with: o GDP, GMP, MDR and IVDR requirements o Vigilance and regulatory reporting requirements o Ensure complaints are assigned, investigated, and closed within defined timelines. o Escalate critical or potentially serious quality issues to the RP/QP/PRRC/Manager as appropriate. Maintain inspection and audit readiness through accurate documentation and record management Perform: o Complaint trending and data analysis o KPI monitoring and reporting o Training coordination for personnel on relevant quality processes Liaise with: o Customers o Suppliers and manufacturers o Regulatory authorities o Internal stakeholders across all departments Quality Management System Responsibilities Administration of Quality Management System (QMS) processes related to complaints, FSCAs and recalls Support quality processes including: o Change Control o Non-Conformance and CAPA management o Internal and external audits o Risk assessment and risk management activities SOP authoring, review and document control administration Completion of customer quality questionnaires and requests Support regulatory activities including liaison with the Health Products Regulatory Authority and Medicines and Healthcare products Regulatory Agency Support quality and compliance-related projects Preparation and submission of monthly, quarterly and annual KPI reports Provide cross-functional support and cover for other team members as required Carry out additional duties appropriate to the role as assigned Desirable Qualifications&Experience Relevant third-level qualification in Science, Quality, Regulatory Affairs or a related discipline Knowledge of pharmaceutical and medical device terminology Working knowledge of ISO 9001 quality systems Experience working within GDP and/or GMP regulated environments Experience using QMS software systems Full Irish driving licence and access to transport desirable Desired Characteristics Proactive with strong organisational skills Flexible and adaptable in a fast-paced regulated environment Strong problem-solving and troubleshooting capability Excellent written and verbal communication skills Strong interpersonal skills with the ability to communicate effectively at all levels internally and externally Ability to work independently while managing multiple priorities High attention to detail and commitment to quality and compliance - FANNIN IS AN EQUAL OPPORTUNITY EMPLOYER - Although the above is a description of the requirements of your job, as stated in your contract of employment, you may be required to carry out other reasonable duties as the Company may require from time to time. Skills: Customer focus Full Clean Driving License Technical skillsTPBN1_IJ