Radiopharmacy QA Specialist

Alliance Medical Ireland; Dublin; On-site; EUR 45,000 - 65,000; Full time

Job summary

Alliance Medical in West Co. Dublin is recruiting a QA Specialist to lead the establishment and ongoing development of our radiopharmaceutical unit, ensuring EU GMP compliance and high quality standards.

You will design and maintain training curricula, manage qualification activities (IQ, OQ, PQ), oversee audits, and collaborate across Quality, Manufacturing and QC to support commissioning and ongoing operations.

Qualifications

• Degree in Life Sciences, Pharmacy, Chemistry, Biotechnology, Engineering, or related field.
• Minimum 3–5 years in a GMP-regulated pharmaceutical or radiopharmaceutical environment.
• Experience developing and managing training programmes and personnel qualification systems.
• Knowledge of radiopharmaceutical manufacturing and aseptic processing is advantageous.

Responsibilities

• Establish, maintain and continuously improve the site's GMP QMS and training programme.
• Design and maintain training curricula, qualification matrices and training plans.
• Coordinate GMP induction, onboarding and ongoing compliance training.
• Monitor training records and ensure inspection readiness.
• Support audits and regulatory inspections with training evidence.

Skills

EU GMP knowledge

GMP training programmes

Quality management systems

Training design & delivery

Cross-functional collaboration

Education

Life Sciences or related degree

Job description

Alliance Medical are delighted to announce we are now hiring a QA Specialist for our Radiopharmacy Unit in West Co. Dublin.

Alliance Medical Radiopharmacy is establishing a new, state-of-the-art radiopharmaceutical production facility in Dublin, designed to provide PET radiotracers to scanning centres across the island of Ireland. This exciting development supports Alliance Medical's vision to place Ireland at the forefront of Radiopharmacy, enhancing access to high-quality PET imaging and contributing to improved outcomes for patients. We are now seeking committed and motivated individuals to join our growing production team. Successful candidates will play an important role in the start-up, operation, and continued development of this new facility, supporting the delivery of safe, reliable, and high-quality radiopharmaceutical services.

We are now recruiting for this rare opportunity, ensuring that our products adhere to the required quality in accordance with EU GMP guidelines as stated in EudraLex Vol. 4.

This exciting role offers a full-time permanent contract, 37.5 hours per week.

Duties To Include:

• Co-ordinating within a team for early morning production and distribution times, typically starting at 3am.

QA Specific Duties-

• Participation in out-of-hours, early morning, weekend or shift work as required by radiopharmaceutical production schedules, typically starting at 3am.
• Establishing, maintaining, and continuously improving the site's GMP QMS, training and qualification programme
• Design and maintain role-based training curricula, qualification matrices, and training plans for all site functions.
• Prepare, review, and manage training materials, SOP training packages, and e-learning content.
• Coordinate GMP induction, onboarding, and ongoing compliance training programmes.
• Maintain training records and ensure document storage and archiving systems are compliant and inspection-ready.
• Monitor training compliance, competency assessments, and qualification status of personnel.

General Duties -

• Generate and report training metrics, KPIs, and compliance trends to site leadership.
• Identify training gaps and implement corrective actions to support compliance and capability development.
• Support facility commissioning, qualification, and operational readiness activities through the development and delivery of training programmes.
• Review and approve commissioning and qualification documentation, including IQ, OQ, and PQ protocols and reports during facility start-up.
• Provide QA oversight for equipment, utilities, systems, and process qualification activities.
• Promote and maintain a strong GMP and quality culture across all functional areas.
• Support internal audits, regulatory inspections, and customer audits by providing evidence of training and personnel qualification compliance.

Skills/Key Competencies & Qualifications:

• Strong knowledge of EU GMP requirements and pharmaceutical quality systems.
• Experience managing GMP training and qualification programmes.
• Understanding of commissioning, qualification, and validation activities (IQ, OQ, PQ).
• Degree in Life Sciences, Pharmacy, Chemistry, Biotechnology, Engineering, or a related discipline.
• Minimum 3-5 years of experience in a GMP-regulated pharmaceutical, biotechnology, medical device, or radiopharmaceutical environment.
• Experience developing and managing training programmes and personnel qualification systems.
• Knowledge of radiopharmaceutical manufacturing and aseptic processing would be advantageous.
• Ability to work collaboratively across Quality, Manufacturing, and QC.