Job Description
Be the Quality Expert Behind the Release of Life-Changing Medicines
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QA GMP Specialist
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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?
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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.
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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.
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What you'll achieve (and why it matters)
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Bring your GMP and Quality Assurance expertise into a varied, client-focused environment where no two projects are necessarily the same.
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Provide Quality Assurance and GMP oversight across a range of pharmaceutical and life sciences activities.
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Support the review of batch documentation and records as part of the batch release process.
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Assist Qualified Persons (QPs) with documentation review and activities supporting batch certification and release.
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Review manufacturing, analytical and quality documentation to ensure compliance with GMP requirements and approved specifications.
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Support investigations into deviations, quality events and manufacturing issues, helping drive effective and compliant resolutions.
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Support CAPA and change control processes, ensuring appropriate actions are identified, implemented and followed through.
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Assess quality events and support the evaluation of their potential impact on product quality and batch release.
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Provide quality oversight and support for activities involving Contract Manufacturing Organisations (CMOs), contract laboratories and external partners.
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Participate in quality reviews, governance activities and client discussions where required.
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Support supplier and vendor qualification activities and quality-related assessments.
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Contribute to GMP audits, inspection readiness and regulatory compliance initiatives.
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Support Quality Management System (QMS) activities and the continuous improvement of quality processes.
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Maintain high standards of GMP documentation and data integrity across all quality activities.
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Collaborate with QPs, GMP professionals, clients and cross-functional stakeholders to ensure quality objectives are achieved.
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Stay focused on patient safety, regulatory compliance and the highest standards of pharmaceutical quality.
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Your edge (desired, not required)
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Bachelor's degree or equivalent qualification in Pharmacy, Chemistry, Biology, Biotechnology, Pharmaceutical Science or another relevant scientific discipline.
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Previous experience in a Quality Assurance, GMP Quality or pharmaceutical quality role.
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Solid working knowledge of EU GMP requirements and pharmaceutical quality systems.
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Experience reviewing GMP documentation and quality records.
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Exposure to batch documentation review, batch release or batch certification activities.
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Experience supporting deviations, investigations, CAPAs and change controls.
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Experience working within a regulated pharmaceutical, biotechnology or life sciences environment.
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Experience working alongside or supporting Qualified Persons (QPs) would be highly advantageous.
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Exposure to commercial medicinal products and/or Investigational Medicinal Products (IMPs) is desirable.
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Experience with Contract Manufacturing Organisations (CMOs), contract laboratories or external suppliers would be beneficial.
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Knowledge of EU GMP Annex 16 and/or Annex 21 would be advantageous.
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Experience supporting GMP audits, regulatory inspections or inspection readiness activities is desirable.
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Strong attention to detail with excellent organisational, communication and problem-solving skills.
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Ability to manage multiple priorities and work effectively across different projects and stakeholders.
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A proactive, collaborative and solutions-focused approach.
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Why this role matters
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Quality is at the heart of every successful pharmaceutical product.
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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.
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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.
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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.
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The next step for you
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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.
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All applications are treated in the strictest confidence.
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📌 Qa Gmp Specialist (Tasmania)
🏢 Next Generation Recruitment
📍 Tasmania