Job Description

Be the Quality Guardian Behind Life-Changing Medicines

Quality Assurance Specialist

Imagine being the person who ensures every batch of medicine meets the highest quality standards before reaching patients. Every review you complete, every investigation you support, and every quality decision you make contributes directly to patient safety and manufacturing excellence.

This is an opportunity to join a world-class sterile pharmaceutical manufacturing facility where quality is embedded into every stage of production. Working alongside manufacturing, engineering, and technical teams, you'll play a critical role in ensuring products are manufactured in full compliance with GMP requirements while driving a culture of continuous improvement and operational excellence.

What you'll achieve (and why it matters)

Bring your quality expertise into a fast-paced pharmaceutical manufacturing environment where precision, compliance, and collaboration make a real difference.

• Provide Quality Assurance support to manufacturing teams throughout daily production activities.

• Review Electronic Batch Records (EBRs), batch documentation, and line clearances to ensure compliance and timely batch release.

• Support investigations into deviations, manufacturing events, and quality issues while helping drive effective resolutions.

• Review quality reports, documentation, and investigation outcomes to maintain the highest compliance standards.

• Promote a Quality Right First Time (QRFT) culture and help maintain continuous audit readiness.

• Carry out production floor quality walkthroughs and spot checks, providing real-time quality oversight.

• Ensure compliance with cGMP, Good Documentation Practices (GDP), and global pharmaceutical regulatory requirements.

• Assist with customer complaint investigations and quality improvement initiatives where required.

• Collaborate closely with Production, Engineering, Quality, and cross-functional teams to strengthen manufacturing performance.

• Support Quality Management System (QMS) activities while maintaining Environmental Health & Safety (EHS) standards.

• Work with industry-leading manufacturing systems including SAP, MES, and TrackWise.

Your edge (desired, not required)

• Bachelor's degree in Chemistry, Biology, Biotechnology, Microbiology, Pharmaceutical Science, or another Science-related discipline.

• 1–2 years' experience in a Quality role within pharmaceutical manufacturing.

• Working knowledge of cGMP and Good Documentation Practices (GDP).

• Experience within a regulated GMP manufacturing environment.

• Strong documentation review skills and experience working with quality systems.

• Excellent organisational, communication, and problem-solving abilities.

• Ability to prioritise effectively and thrive in a fast-paced manufacturing environment.

• Experience within sterile or aseptic pharmaceutical manufacturing would be highly advantageous.

• Experience using SAP, MES, TrackWise, or similar pharmaceutical manufacturing systems is desirable.

• Knowledge of European and international pharmaceutical regulations is beneficial.

• Previous experience supporting batch review, deviations, investigations, or audit readiness activities would be an advantage.

Why this role matters

Quality is at the heart of pharmaceutical manufacturing. In this position, you'll be the link between production and compliance, ensuring every product is manufactured to the highest standards before it reaches the people who rely on it.

You'll gain hands-on experience within sterile manufacturing, work alongside experienced technical professionals, and further develop your expertise in GMP, quality systems, batch review, investigations, and manufacturing excellence—all within a globally recognised pharmaceutical environment.

The next step for you

If this opportunity is of interest, please send your CV to danielle.johnson@nextgeneration.ie or reach out to discuss the role further.

All applications are treated in the strictest confidence.

Next Generation Recruitment specialises in Supply Chain, Procurement, Engineering, Quality, Technical, Scientific, Manufacturing, and Operations recruitment across permanent, contract, and temporary positions.

Your personal data will never be shared outside our organisation without your prior written consent.