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.
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