Quality Assurance Specialist – Pharmaceutical

Quality Assurance Specialist – Pharmaceutical

We are seeking a Quality Assurance Specialist to support quality operations within a GMP-regulated pharmaceutical environment. The successful candidate will be responsible for ensuring compliance with quality standards, supporting product and material release, and maintaining effective Quality Management Systems (QMS).

Key Responsibilities

• Support the release of incoming materials, outsourced products and manufacturing batches in accordance with GMP and regulatory requirements.
• Manage and support Quality Management Systems, including deviations, CAPAs, change controls, complaints and annual product reviews (APRs).
• Perform batch record reviews and ensure accurate documentation.
• Ensure compliance with GMP, GDP and data integrity (ALCOA) principles.
• Support quality investigations, documentation reviews and continuous improvement initiatives.
• Work closely with manufacturing, supply chain, suppliers and other departments to resolve quality issues.
• Support the introduction of new materials and products to site.
• Assist with audit preparation, inspection readiness and quality compliance activities.

Requirements

• Previous experience in the pharmaceutical industry is essential.
• Quality Assurance experience is preferred.
• Knowledge of GMP regulations and Quality Management Systems.
• Familiarity with deviations, complaints, CAPAs, change control, annual product reviews and batch record review.
• Excellent communication and organisational skills.
• Strong attention to detail and documentation skills.
• Ability to work independently and collaborate with cross-functional teams.

Desirable

• Bachelor's degree in Science, Quality, Pharmaceutical Sciences or a related discipline.
• Experience with electronic QMS systems.
• Experience supporting product release, audits and regulatory compliance.
• Previous experience working with suppliers and outsourced manufacturing operations.

Working Arrangement: This is a hybrid, day-shift position, requiring a minimum of 2–3 days onsite per week, with no shift work involved.

This is an 11-month contract position based in Carlow, with a salary starting from €55,000 per annum. To hear more about this opportunity or to discuss your suitability, please apply today!

If you would like to know more about this role, you can reach me at anamarija.bratovic@recruiters.ie You can also apply using the “Apply Now” button below.

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