Quality Complaint & Recall Administrator

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