Radiopharmacy Quality Assurance Specialist

1 week ago

Dublin, Dublin City, Ireland beBeeRadiopharmacy Full time €60,000 - €80,000

Job Summary

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The Radiopharmacy Head of Quality Control oversees the quality control function, ensuring radiopharmaceutical products meet high standards before patient delivery.

This is a full-time position with a 37.5 hour workweek and a permanent contract.

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  • Establish quality standards for radiopharmaceuticals according to marketing authorisation, manufacturing licence, and EU-GMP Guidelines.">
  • Manage a team of QC chemists analysing PET tracers with early production and distribution times.">
  • Guarantee testing of raw materials, intermediates, finished products, containers, packaging, labelling materials, and leaflets per written instructions and GMP.">
  • Approve test instructions, specifications, and sampling plans (EU-GMP Ch. 4 & 6) and keep them current.">
  • Verify test instructions against dossier/CTA file and ensure compliance.">
  • Document and investigate all deviations.">
  • Approve or reject materials and intermediates.">
  • Decide on, contract, and supervise external testing labs.">
  • Oversee maintenance and qualification of QC premises/equipment.">
  • Validate and periodically review analytical methods and critical tests.">
  • Organise personnel training.">
  • Monitor storage conditions for samples and standards.">
  • Notify authorities of material changes.">
  • Carry out trend analyses and QC-specific management duties.">
  • Responsible for the management of engaged and motivated QC chemists, effectively utilising internal resources and supports.">
  • Assist in developing and implementing standard operating procedures and training plans for the team.">
  • Recommend new processes to enhance operational effectiveness.">

Required Skills and Qualifications

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  • Certified Qualified Person (QP) status by HPRA or relevant regulatory authority.">
  • Completed scientific training plus at least 1-year practical experience in nuclear medicine or (radio)pharmaceutical chemistry environment.">
  • Completed scientific/medical university degree.">
  • Leadership/Management qualification desirable.">
  • An understanding of and track record of implementing regulatory guidelines.">
  • Technically competent: high technical skill level.">
  • Excellent communication and people skills.">
  • Team leadership skills: to motivate and lead strong teams.">

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