Medical Device Regulatory jobs

Job Summary:

We are currently recruiting for a number of QA Specialist to join a leading global biopharmaceutical manufacturer based in the South East of Ireland on an initial 12–18 month contract.

This is an excellent opportunity to join a high-performing Quality team supporting GMP manufacturing operations in a regulated environment. The successful candidate will play a key role in ensuring compliance with cGMP requirements, supporting quality systems, and driving continuous improvement initiatives across site operations.

Key Responsibilities:

• Act as a Quality Assurance representative, providing guidance and support on GMP quality systems and processes.
• Review and approve GMP documentation, including batch records, SOPs, investigations, protocols, and reports.
• Support the investigation and timely closure of deviations, CAPAs, change controls, and quality actions.
• Participate in the development and delivery of GMP training programmes.
• Conduct internal audits and support supplier, customer, and regulatory inspections.
• Ensure products are manufactured, stored, and packaged in accordance with cGMP requirements.
• Monitor quality metrics, identify trends, and support continuous improvement initiatives.
• Collaborate with cross-functional teams to resolve quality issues and maintain compliance.
• Contribute to the ongoing maintenance and effectiveness of the site's Quality Management System (QMS).

Requirements:

• Bachelor's degree in Science, Pharmacy, Engineering, or a related discipline.
• Minimum of 3 years' Quality Assurance experience within a GMP-regulated pharmaceutical, biotechnology, or medical device environment.
• Strong knowledge of GMP, GDP, FDA, EMA, and EU GMP requirements.
• Experience working with quality systems including deviations, CAPAs, change controls, investigations, and document control.
• Proven experience reviewing GMP documentation, including batch records and SOPs.
• Experience supporting internal, supplier, and regulatory audits.
• Strong analytical, problem-solving, and communication skills.
• Experience with electronic Quality Management Systems (eQMS) and Microsoft Office is desirable.

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