Radiopharmacy Head of Quality Control (Qualified Person)

• 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.
• Ensure results are documented.
• Sign and date test records to confirm compliant testing.
• Ensure compliant shelf-life labelling.
• 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 including induction, buddy system, performance management, delegation, career development, One-to-ones and training.
• Assist in developing and implementing standard operating procedures and training plans for the team.
• Recommend new processes to enhance operational effectiveness.
• Undertake tasks as directed by the site manager to ensure the project is delivered on time and on budget.
• Set clear objectives and fully train all new staff members and ensure all staff are trained in all aspects and duties required on site to ensure resilience during periods of staff leave.
• Record and maintain training competency checklist for new starters during training until all training is complete.
• Manage staff roster and annual leave/absence requests.
• Organise weekly and monthly staff meetings, compile minutes and agendas.

• SOP/GMP document control, dossier work, EHS compliance, clean-room monitoring, supplier oversight, validations, audits, complaints & recalls, etc.

• Qualified Person (QP) status certified by HPRA or relevant regulatory authority.
• Completed scientific training plus ≥ 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.

• Excellent attention to detail.
• Excellent communication and leadership skills.
• Demonstrates initiative and highly motivated.
• Ability to work in a challenging environment with changing priorities.
• Flexibility and adaptability.
• Proven organisational skills.
• Evidence of teamwork/strong team player.

Alliance Medical