Radiopharmacy Head Of Quality Assurance

4 weeks ago

Dublin, Ireland Alliance Medical Ireland Full time

Overview
Alliance Medical Ireland are hiring a Radiopharmacy Head of Quality Assurance (Qualified Person) to lead the QA team and safeguard product quality, patient safety and regulatory compliance.
This is a full-time (37.5 hours per week), permanent role.
Closing date: Friday 19 September 2025.
Responsibilities
Coordinate and lead all QA activities.
Regularly review and adapt QA/QC systems to current science and technology.
Translate laws, regulations and guidelines into the QA system.
Conduct GMP self-inspections and supplier/contract-lab audits.
Ensure quality issues are fully documented, investigated and resolved (change control, deviations, OOS/OOT).
Liaise with authorities (e.g. HPRA/EPA) and prepare/host inspections.
Batch certification and release per written procedures.
Ensure radioactive medicines are supplied only to authorised holders.
Ensure retention samples of each batch are kept at least six months beyond expiry, and raw-material samples at least two years after release; define responsibilities contractually if multiple sites are involved.
Oversee storage conditions for retain samples.
Ensure retention of IMP samples for 2 years after last clinical use.
Fulfil Annex 19 & 16 EU-GMP requirements (proc. validation, documentation review, PQR creation, change control, etc.).
Co-operate with authorities, organise inspections, plan & deliver GMP training.
Responsible for the management of an engaged and motivated team, 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.
Qualifications
Quality Person 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.
High level of regulatory competence and experience.
Excellent communication and people skills.
Team leadership skills: to motivate and lead strong teams.
Qualities
Excellent attention to detail and customer service orientation.
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.
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