Job Description

Be the Quality Expert Behind the Release of Life-Changing Medicines

QA GMP Specialist

What if your quality expertise could help ensure that patients receive safe, compliant, high-quality medicines - while giving you exposure to a diverse range of pharmaceutical clients and GMP activities?

This is an opportunity to join a specialist pharmaceutical quality team where your expertise will contribute directly to GMP compliance, quality oversight and batch release activities.

Working alongside experienced Quality professionals and Qualified Persons (QPs), you'll play a key role in reviewing critical documentation, supporting batch release activities, managing quality events and ensuring pharmaceutical products meet the highest standards of quality and regulatory compliance.

What you'll achieve (and why it matters)

Bring your GMP and Quality Assurance expertise into a varied, client-focused environment where no two projects are necessarily the same.

• Provide Quality Assurance and GMP oversight across a range of pharmaceutical and life sciences activities.

• Support the review of batch documentation and records as part of the batch release process.

• Assist Qualified Persons (QPs) with documentation review and activities supporting batch certification and release.

• Review manufacturing, analytical and quality documentation to ensure compliance with GMP requirements and approved specifications.

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

• Support CAPA and change control processes, ensuring appropriate actions are identified, implemented and followed through.

• Assess quality events and support the evaluation of their potential impact on product quality and batch release.

• Provide quality oversight and support for activities involving Contract Manufacturing Organisations (CMOs), contract laboratories and external partners.

• Participate in quality reviews, governance activities and client discussions where required.

• Support supplier and vendor qualification activities and quality-related assessments.

• Contribute to GMP audits, inspection readiness and regulatory compliance initiatives.

• Support Quality Management System (QMS) activities and the continuous improvement of quality processes.

• Maintain high standards of GMP documentation and data integrity across all quality activities.

• Collaborate with QPs, GMP professionals, clients and cross-functional stakeholders to ensure quality objectives are achieved.

• Stay focused on patient safety, regulatory compliance and the highest standards of pharmaceutical quality.

Your edge (desired, not required)

• Bachelor's degree or equivalent qualification in Pharmacy, Chemistry, Biology, Biotechnology, Pharmaceutical Science or another relevant scientific discipline.

• Previous experience in a Quality Assurance, GMP Quality or pharmaceutical quality role.

• Strong working knowledge of EU GMP requirements and pharmaceutical quality systems.

• Experience reviewing GMP documentation and quality records.

• Exposure to batch documentation review, batch release or batch certification activities.

• Experience supporting deviations, investigations, CAPAs and change controls.

• Experience working within a regulated pharmaceutical, biotechnology or life sciences environment.

• Experience working alongside or supporting Qualified Persons (QPs) would be highly advantageous.

• Exposure to commercial medicinal products and/or Investigational Medicinal Products (IMPs) is desirable.

• Experience with Contract Manufacturing Organisations (CMOs), contract laboratories or external suppliers would be beneficial.

• Knowledge of EU GMP Annex 16 and/or Annex 21 would be advantageous.

• Experience supporting GMP audits, regulatory inspections or inspection readiness activities is desirable.

• Strong attention to detail with excellent organisational, communication and problem-solving skills.

• Ability to manage multiple priorities and work effectively across different projects and stakeholders.

• A proactive, collaborative and solutions-focused approach.

Why this role matters

Quality is at the heart of every successful pharmaceutical product.

In this role, you'll contribute to the quality oversight and release of medicinal products, helping ensure that every batch meets the required standards before reaching the patients who depend on them.

You'll work alongside experienced Quality professionals and Qualified Persons, developing your expertise across GMP compliance, batch review, batch release, quality systems, investigations, CAPAs, audits and regulatory readiness.

For a QA professional looking to broaden their experience beyond a traditional single-site quality role, this is an opportunity to gain exposure to a diverse range of pharmaceutical quality activities while making a meaningful contribution to patient safety.

The next step for you

If you're an experienced QA or GMP Quality professional looking for your next opportunity in the Midlands, Ireland, we'd love to hear from you.

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.