Turn Your Quality Expertise Into GMP-Driven Pharmaceutical Manufacturing
Quality Assurance Specialist
Imagine using your quality expertise to help maintain the standards, compliance, and product quality behind a highly regulated pharmaceutical manufacturing environment.
This is an opportunity to join a pharmaceutical quality team in Carlow, Co. Carlow, supporting product and material release, quality systems, investigations, and manufacturing documentation. You'll work alongside Manufacturing, Engineering, Laboratory, Supply Chain, and Technical Operations teams to ensure quality requirements are consistently met.
This role is suited to an experienced QA or Quality Specialist who combines strong GMP knowledge with excellent attention to detail, sound judgement, and the ability to manage quality activities across a busy manufacturing environment.
What you'll achieve (and why it matters)
- Support the release of incoming materials and goods against approved quality requirements.
- Support the release of products manufactured or packaged through external operations.
- Review batch records, electronic batch records, material documentation, real-time reports, and master data.
- Support the introduction of new products and materials into the manufacturing site.
- Manage quality records relating to deviations, CAPAs, change controls, investigations, complaints, and document management.
- Monitor Quality Management System (QMS) activities and generate relevant quality metrics and reports.
- Identify, assess, and escalate potential GMP or product-quality issues.
- Apply ALCOA data integrity principles to quality records and activities.
- Work with Quality teams and Qualified Persons (QPs) to resolve quality-related matters.
- Support audit and inspection readiness across relevant quality activities.
- Communicate quality requirements to internal stakeholders and suppliers.
- Identify opportunities to improve quality processes and support efficient batch-release activities.
- Maintain compliance with approved procedures and Good Documentation Practices.
Your edge (desired, not required)
- Bachelor's degree in Science, Engineering, Quality, Biotechnology, Pharmaceutical Sciences, Chemistry, Microbiology, or a related technical discipline.
- Typically 3-5 years' experience in a regulated pharmaceutical, biotechnology, medical device, healthcare, or similar manufacturing environment.
- Previous experience in Quality Assurance, Quality Systems, or Quality Compliance.
- Practical knowledge of GMP/cGMP requirements.
- Hands-on experience managing deviations, CAPAs, change controls, and investigations.
- Experience reviewing manufacturing or quality documentation.
- Understanding of data integrity and ALCOA principles.
- Experience with batch release, material release, or electronic batch records is advantageous.
- Exposure to complaints, APR/PQR, supplier quality, or new product introduction is beneficial.
- Experience supporting audits, inspections, or regulatory compliance activities.
- Experience working with Qualified Persons (QPs) is advantageous.
- Strong analytical, organisational, and problem-solving skills.
- Excellent written and verbal communication skills.
- Ability to manage competing priorities and work effectively with moderate direction.
- Proficiency with Microsoft Office and electronic quality management systems.
The next step for you
If this opportunity is of interest, please send your CV to 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.
