Qualified Person

Alliance Medical Ireland; Dublin; On-site; EUR 90,000 - 130,000; Full time

Job summary

Alliance Medical Ireland seeks a Qualified Person for our Radiopharmacy Unit in West Co. Dublin to certify radiopharmaceutical batches for market release under Article 51 of Directive 2001/83/EC.

You will lead the Quality Management System, ensure GMP compliance, and oversee regulatory inspections, supplier quality, deviations, CAPAs, and audits, contributing to site-wide continuous improvement.

Role includes out-of-hours and early shifts as required by production schedules.

Qualifications

• Qualified Person eligibility under EU Directive 2001/83/EC is required.
• Minimum 5 years as an acting QP on Manufacturer's Authorisation.
• Minimum 8+ years' experience in pharmaceutical or radiopharmaceutical manufacturing.
• Experience with batch certification and GMP quality systems.
• Experience with supplier qualification and vendor management.
• Strong knowledge of EU GMP and radiopharmaceutical regulations.

Responsibilities

• Participate in out-of-hours, early morning, weekend or shift work as required by production schedules.
• Act as a Qualified Person (QP) certifying radiopharmaceutical batches for release to market.
• Ensure products are manufactured, tested, and released in compliance with GMP, MA, and regulatory requirements.
• Lead the establishment, maintenance, and continuous improvement of the QMS.
• Provide quality oversight for deviations, CAPAs, change controls, investigations, and risk assessments.
• Support supplier quality management, including vendor qualification and audits.
• Provide oversight of sterile and aseptic manufacturing, contamination control, and environmental monitoring.
• Act as the Quality SME during regulatory inspections and audits.
• Collaborate with Manufacturing & QC to ensure compliant product disposition.
• Drive inspection readiness and quality culture site-wide.
• Mentor Quality team and maintain knowledge of GMP and regulations.

Skills

QP responsibilities

EU GMP knowledge

Quality management

Regulatory compliance

Leadership & stakeholder mgmt

Risk-based decision making

Education

Degree in Pharmacy or related

Job description

Alliance Medical are delighted to announce we are now hiring a Qualified Person 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.

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

Duties to Include

• Participation in out-of-hours, early morning, weekend or shift work as required by radiopharmaceutical production schedules, typically starting at 3am.
• Act as a Qualified Person (QP) in accordance with Article 51 of Directive 2001/83/EC, certifying radiopharmaceutical batches for release to market.
• Ensure products are manufactured, tested, and released in compliance with GMP, Marketing Authorisations, and applicable regulatory requirements.
• Lead the establishment, maintenance, and continuous improvement of the Quality Management System (QMS).
• Provide quality oversight for deviations, CAPAs, change controls, investigations, and risk assessments.
• Support supplier quality management, including vendor qualification, supplier audits, quality agreements, and ongoing performance monitoring.
• Provide oversight of sterile and aseptic radiopharmaceutical manufacturing, contamination control, and environmental monitoring programs.
• Act as the Quality SME during regulatory inspections, customer audits, and authority interactions.
• Collaborate with Manufacturing & QC to ensure compliant and timely product disposition.
• Drive inspection readiness, quality culture, and continuous improvement initiatives across the site
• Mentor and support Quality team development while maintaining current knowledge of GMP and radiopharmaceutical regulations.

Skills/Key Competencies & Qualifications

• Strong knowledge of EU GMP requirements, radiopharmaceutical manufacturing, and batch certification responsibilities.
• Ability to make risk-based quality decisions while ensuring patient safety and regulatory compliance.
• Experience with Quality Management Systems, supplier quality management, and regulatory inspections.
• Excellent leadership, communication, stakeholder management, and problem-solving skills.
• Strong organizational skills with the ability to manage multiple priorities in a fast-paced GMP environment.

Qualities

• Degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Microbiology, Engineering, or a related scientific discipline.
• Eligible to act as a Qualified Person under EU Directive 2001/83/EC with a minimum of 5 years' experience as an acting QP named on a Manufacturer's Authorisation.
• Minimum 8+ years' experience in pharmaceutical or radiopharmaceutical manufacturing, with experience in sterile/aseptic operations preferred.
• Demonstrated experience in batch certification, GMP quality systems, and regulatory compliance.
• Experience establishing or managing Quality Management Systems (QMS).
• Experience in supplier qualification, vendor management, and quality auditing.
• Strong knowledge of EU GMP, Annex 1, Annex 3, Annex 16, HPRA and radiopharmaceutical regulations.