Quality Graduate

Description

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

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

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

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.

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.

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.