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. 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 Person3+ years QA experience in a HPRA/FDA/EU & GMP/GDP regulated environmentThorough knowledge of temperature-controlled activitiesThorough knowledge of cGMPs/GDPs and global regulatory requirementsSound 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 environmentGood verbal and written communication skills with well-structured communication and ability to present to various audience levelsLeinster Appointments is committed to providing a professional service where all CVs are kept confidential and will not be submitted to any third parties without candidate's knowledge or consent.
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