The Role

Leinster Appointments is currently recruiting for a Quality Specialist in Dublin 12. 

This is a permanent, full time role. 

Fully office based

Key Responsibilities

• Support the development, implementation, and ongoing maintenance of the Quality Management System (QMS).
• Ensure compliance with GDP guidelines (2013/C 343/01) and HPRA requirements (IA-G0046) across all distribution activities.
• Promote a strong quality culture through continuous training, retraining, and effective communication of quality processes.
• Oversee training requirements: ensuring all new hires receive initial GDP training and that a structured ongoing training programme is in place for all employees.
• Verify that only authorised product classes are sourced from approved suppliers and supplied to approved customers in line with the company’s WDA.
• Assist with the qualification and approval of outsourced service providers and transport routes as required.
• Review, draft, and implement controlled documentation including SOPs, deviations, change controls, validations, and related records.
• Perform initial and ongoing bona fide checks on suppliers and customers as assigned.
• Contribute to the maintenance of a company-wide risk management culture.
• Review and update Quality Technical Agreements, ensuring agreements are in place with all relevant suppliers, customers, and service providers.
• Manage product returns within the supply chain: secure handling, appropriate reporting to the Responsible Person (RP), and ensuring non-compliant products are not released for sale.
• Assess temperature-controlled shipments and provide quality decisions regarding product impact.
• Monitor all temperature-controlled activities within the supply chain, including warehouse conditions.
• Escalate suspected adverse drug reactions (ADRs) or product quality defects to the RP for reporting to Competent Authorities and Product Authorisation holders.
• Coordinate and execute product recalls in a compliant and timely manner.
• Act as Deputy Responsible Person (dRP) on the company’s Wholesale Authorisation, assuming RP duties during their absence with appropriate handover.
• Execute delegated RP responsibilities and ensure accurate record keeping of these activities.
• Safeguard continuity of supply while ensuring that commercial decisions never compromise product quality, patient safety, or compliance.
• Escalate any suspected falsified medicines to the Competent Authorities and Product Authorisation holders without delay.
• Maintain accuracy and integrity of quality records and all GDP-related documentation.
• Undertake additional projects or duties as assigned by the Quality Manager or RP.

The Person

• Over 5 years’ experience in Quality Assurance within an HPRA/EU GDP regulated environment.
• Strong expertise in temperature-controlled activities.
• In-depth knowledge of Good Distribution Practice (GDP) and international regulatory requirements governing the wholesale of medicinal products.
• Solid understanding of pharmaceutical Wholesale Distribution Authorisation (WDA) business models, particularly from a quality and compliance perspective.
• Excellent interpersonal skills with the ability to collaborate effectively across functions within a matrix organisation.
• Clear and structured communicator, both verbally and in writing, with the ability to present information to audiences at different levels.
• Previous experience within a pharmaceutical wholesale environment is highly desirable.
• Experience with Medical Devices is advantageous but not essential.