Job Description

Take Your Quality Career Further in Pharmaceutical Manufacturing

Quality Assurance Specialist 

Ready for your next move in Quality Assurance? This is an opportunity to bring your expertise into a highly regulated pharmaceutical manufacturing environment in Carlow, where you'll play a key role in supplier quality, GMP compliance and quality assurance.

You'll work across supplier qualification, supplier audits, Quality Agreements and quality systems, collaborating with Quality, Engineering, Manufacturing and Supply Chain teams to support product quality and regulatory compliance.

With a strong focus on supplier quality and cross-functional collaboration, this role offers the opportunity to expand your technical experience, take ownership of important quality activities and contribute to continuous improvement in a demanding pharmaceutical environment.

Enjoy the benefits of a hybrid working arrangement, standard weekday hours and no shift work, while gaining valuable experience across supplier quality and pharmaceutical quality systems.

What you'll be working on

• Take ownership of key supplier quality activities, including qualification, ongoing management and periodic re-evaluation.
• Manage Quality Agreements and support associated annual product review activities.
• Oversee the Approved Supplier List and ensure suppliers and materials meet quality requirements.
• Monitor supplier performance, contribute to supplier reviews and participate in material review boards.
• Conduct and support audits across procedures, equipment, systems, computer systems, data and facilities.
• Review and approve production and analytical documentation associated with API, safety assessment and clinical supply lot release.
• Support supplier complaints, deviations, investigations, CAPAs and corrective actions.
• Manage and support change controls, helping maintain compliance and effective quality systems.
• Support new product and material introductions through documentation review and supplier qualification.
• Author, review and approve protocols and reports for technology transfer, method qualification and method validation.
• Prepare audit reports, communicate findings and work with relevant teams to implement corrective actions.
• Support GMP compliance, inspection readiness and regulatory requirements while contributing to site Quality initiatives.

What will make you stand out

We're looking for a quality professional who understands the demands of a regulated environment and can combine technical expertise with strong communication and stakeholder management skills.

You'll ideally bring:

• 3–5+ years of Quality Assurance experience, preferably within pharmaceutical manufacturing.
• Experience in pharmaceutical, biopharmaceutical, chemical or another regulated industry.
• Strong working knowledge of cGMP regulations and quality compliance.
• Hands-on experience in supplier quality management, supplier qualification or supplier oversight.
• Experience with Quality Agreements, supplier audits or supplier performance management.
• Practical experience with deviations, CAPAs, change controls and supplier complaints.
• Strong technical writing, documentation and report-writing skills.
• Excellent problem-solving, organisational and decision-making abilities.
• The ability to work independently and collaborate effectively across cross-functional teams.
• A Bachelor's degree or higher in a relevant Science discipline is preferred.

Additional experience that could give you an edge:

• Managing Approved Supplier Lists and supplier qualification programmes.
• Quality Agreement ownership and supplier performance reviews.
• GMP and GDP within pharmaceutical manufacturing.
• Equipment and process validation.
• Sterile filling processes and equipment.
• Technology transfer, method qualification or method validation.
• Lean Six Sigma and continuous improvement initiatives.
• Familiarity with Irish, European and international regulatory requirements.

Ready to take the next step?

Send your CV to danielle.johnson@nextgeneration.ie or get in touch for a confidential conversation about the role.

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.