Business Unit: Supply Chain & Distribution Overview: This rotation develops foundational knowledge of quality processes within large-scale pharmaceutical and medical distribution operations. You will support GDP-compliant activities, operational quality problem-solving, and system improvements that support product integrity and regulatory compliance.
Key Responsibilities:
· Support GDP (Good Distribution Practice) compliance across warehouse and logistics operations.
· Assist with deviations, CAPAs, change controls, and quality investigations.
· Assist with bona fides and the qualification of suppliers and customers.
· Assist with support of Global quality systems.
· Conduct data gathering, quality reviews, and trend analysis (temperature excursions, returns, complaints).
· Participate in internal audits and support readiness for HPRA inspections.
· Contribute to continuous improvement projects aimed at driving operational excellence.
What you will learn:
· Core GDP principles
· Quality systems in a regulated supply chain
· Risk assessment & decision-making fundamentals
· Root cause analysis methodologies
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Rotation 2: MedTech Quality
Business Unit: Medical Technology Overview: This rotation provides exposure to ISO 13485 environments, product quality assurance, supplier quality, and MedTech regulatory obligations related to medical devices.
Key Responsibilities:
· Support the QMS in line with ISO 13485 / 90001 requirements.
· Assist with post-market surveillance (complaints, FSNs, vigilance reporting).
· Support with the triaging of regulatory queries.
· Participate in supplier qualification and ongoing supplier performance monitoring.
· Review and register device documentation, product releases, and quality records.
· Support process and product audits, risk management files, and design dossier maintenance.
What you will learn:
· ISO 13485 requirements and MedTech regulatory frameworks
· Post-market surveillance & complaint handling
· Supplier quality management
· Documentation control & product lifecycle quality
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Rotation 3: Proluca Quality (MAH Responsibilities)
Business Unit: Proluca – Market Authorisation Holder Overview: This rotation focuses on MAH obligations including pharmacovigilance support, product quality oversight, artwork & batch release processes, and compliance with regulatory authorities.
Key Responsibilities:
· Support the QMS in line with GxP requirements.
· Support MAH quality processes including product release, quality defect investigations, and recalls.
· Assist with PV activities: literature screening, safety data processing, follow-ups, and QPPV support.
· Review artwork, packaging, and labelling for regulatory and quality accuracy.
· Maintain and update PSMFs, product dossiers, and regulatory submission documentation.
· Contribute to HPRA reporting obligations and compliance tracking.
What you will learn:
· MAH roles and responsibilities under HPRA and EMA frameworks
· Pharmacovigilance fundamentals
· Regulatory documentation pathways
· Product quality oversight for medicinal products
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4. What You Will Learn & Deliver
Throughout the graduateship, you will:
· Gain a strong understanding of regulatory frameworks (GDP, GMP, ISO 13485, ISO 9001, MAH).
· Build practical skills in quality investigations, auditing, CAPA management, and compliance reporting.
· Deliver accurate and timely quality documentation, reports, and analysis.
· Contribute to cross-functional projects and continuous improvement initiatives.
· Develop communication, collaboration, and stakeholder management skills across diverse business functions.
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5. Required Skills & Knowledge
· Strong analytical and problem-solving skills.
· Excellent communication and documentation skills.
· Organised, detail-oriented, and able to manage multiple tasks.
· Proactive, willing to learn, and comfortable working in regulated environments.
· Eligibility to work in the relevant jurisdiction.
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6. Education & Qualifications
A degree (or equivalent practical experience) in:
· Science, Quality, Engineering, Pharmacy, Life Sciences, or a related field. Experience through internships, projects, or placements in regulated sectors is beneficial but not required.