Leinster Appointments is currently recruiting for a Quality Specialist.
The role is located in Offaly but the company can also accommodate someone from an office in West Dublin.
This is a permanent, full time role.
Fully office based
Salary up to €60,000 depending on experience, plus great benefits.
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.
Profile Requirements
* 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.
#J-18808-Ljbffr