The Role

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

This is a permanent, full time role.

Fully site based in Dublin 12.

Main duties: 

• Assist in the development, implementation, and maintenance of the Quality Management System (QMS) while ensuring compliance with GDP guidelines (2013/C 343/01) and HPRA guidelines (IA-G0046).
• Ensure all staff are trained upon joining and that a continuous training program is in place for new and existing employees, promoting compliance through regular training and clear communication.
• Procure only authorized product classes from approved suppliers and supply them to approved customers under the Company’s Wholesale Distribution Authorisation.
• Support the approval of outsourced service providers and assist with transport provider route qualifications as needed.
• Review, draft, and approve documentation such as SOPs, change controls, deviations, and validation records, while ensuring accuracy in quality records and GDP systems.
• Perform initial and ongoing Bona Fide checks on suppliers and customers.
• Maintain a companywide risk management culture and ensure Quality Technical Agreements are in place and updated with suppliers, customers, and service providers.
• Manage returns by ensuring they are held securely, reported to the RP, and not made available for sale unless approved.
• Assess temperature-controlled shipments and provide quality decisions, while monitoring all temperature-controlled activities, including warehouse conditions.
• Escalate any known or suspected Adverse Drug Reactions (ADRs), serious product quality defects, or falsified medicines to the RP for reporting to authorities and authorization holders.
• Coordinate product recalls promptly and in a controlled, compliant manner.
• Support the continuity of supply while ensuring no commercial decisions compromise product quality, patient safety, or regulatory compliance.
• Carry out additional duties or projects as assigned by the Quality Manager.

The Person

• 3+ years QA experience in a HPRA/FDA/EU & GMP/GDP regulated environment
• Thorough knowledge of temperature-controlled activities
• Thorough knowledge of cGMPs/GDPs and global regulatory requirements
• Sound awareness and understanding of pharmaceutical WDA business models, especially with regards to quality and regulatory requirements.
• Strong Interpersonal skills and ability to interact constructively with all functions in a matrix organization environment
• Good verbal and written communication skills with well-structured communication and ability to present to various audience levels