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.
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* Manage a team of QC chemists analysing PET tracers with early production and distribution times.
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* Guarantee testing of raw materials, intermediates, finished products, containers, packaging, labelling materials, and leaflets per written instructions and GMP.
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* Approve test instructions, specifications, and sampling plans (EU-GMP Ch. 4 & 6) and keep them current.
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* Verify test instructions against dossier/CTA file and ensure compliance.
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* Document and investigate all deviations.
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* Approve or reject materials and intermediates.
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* Decide on, contract, and supervise external testing labs.
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* Oversee maintenance and qualification of QC premises/equipment.
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* Validate and periodically review analytical methods and critical tests.
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* Organise personnel training.
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* Monitor storage conditions for samples and standards.
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* Notify authorities of material changes.
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* Carry out trend analyses and QC-specific management duties.
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* Responsible for the management of engaged and motivated QC chemists, effectively utilising internal resources and supports.
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* Assist in developing and implementing standard operating procedures and training plans for the team.
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* Recommend new processes to enhance operational effectiveness.
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Required Skills and Qualifications
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* Certified Qualified Person (QP) status by HPRA or relevant regulatory authority.
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* Completed scientific training plus at least 1-year practical experience in nuclear medicine or (radio)pharmaceutical chemistry environment.
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* Completed scientific/medical university degree.
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* Leadership/Management qualification desirable.
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* An understanding of and track record of implementing regulatory guidelines.
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* Technically competent: high technical skill level.
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* Excellent communication and people skills.
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* Team leadership skills: to motivate and lead strong teams.
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