Senior Qualified Person – Radiopharmaceuticals GMP Leader

Alliance Medical Ireland; Dublin; Presencial; EUR 90.000 - 130.000; Jornada completa

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

QP responsibilities

EU GMP knowledge

Quality management

Regulatory compliance

Leadership & stakeholder mgmt

Risk-based decision making

Educación

Degree in Pharmacy or related

Descripción del empleo

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.