Position: Quality Specialist & Deputy Responsible Person (dRP)
Reporting to: Quality Manager
Contract: Permanent, Full-Time
Location: Site-Based – Dublin or Offaly

Role Overview

This position is responsible for providing quality oversight of product distribution within the supply chain. The role ensures that all product shipments are managed in compliance with Good Distribution Practice (GDP) requirements and applicable internal procedures.

The successful candidate will support Logistics, Customer Service, and Commercial functions while maintaining the highest standards of quality and regulatory compliance.

Experience & Qualifications

• Minimum 5+ years’ QA experience in an HPRA/EU GDP-regulated environment
• Strong knowledge of temperature-controlled distribution activities
• In-depth understanding of Good Distribution Practice and global regulatory requirements for medicinal product wholesaling
• Good understanding of pharmaceutical Wholesale Distribution Authorisation (WDA) business models, particularly quality and regulatory aspects
• Excellent interpersonal skills with the ability to work effectively across a matrix organisation
• Strong verbal and written communication skills, with the ability to present to different audience levels
• Previous experience within a pharmaceutical wholesaler environment (preferred)
• Experience with medical devices (desirable but not essential)

Key Responsibilities

• Support the development, implementation, and maintenance of the Quality Management System (QMS)
• Ensure compliance with GDP (2013/C 343/01) and HPRA guidelines (IA-G0046) across all activities
• Promote quality awareness through training, retraining, and effective communication
• Ensure all employees receive appropriate onboarding and ongoing GDP training
• Verify that products are sourced from approved suppliers and distributed to approved customers in line with the Wholesale Distribution Authorisation
• Assist in the qualification and approval of outsourced service providers and transport routes
• Prepare, review, and implement quality documentation (e.g. deviations, change controls, validations, SOPs)
• Perform initial and ongoing Bona Fide checks on suppliers and customers
• Support a company-wide risk management culture
• Maintain and review Quality Technical Agreements with relevant stakeholders
• Manage product returns in compliance with GDP requirements, ensuring appropriate segregation and RP approval
• Assess temperature-controlled shipments and make quality decisions on product disposition
• Monitor temperature-controlled activities, including warehouse conditions
• Escalate adverse reactions, product quality defects, or falsified medicines in line with regulatory requirements
• Coordinate and manage product recalls in a compliant and timely manner
• Act as Deputy Responsible Person (dRP), fulfilling RP duties in their absence and ensuring proper handover processes
• Maintain accurate and compliant quality records across all systems
• Ensure supply continuity while prioritising product quality and patient safety
• Support additional duties and projects as assigned by the Quality Manager and Responsible Person