▷ (High Salary) Quality Specialist, Dublin 12

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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