Quality Complaint & Recall Administrator

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.