Alliance Medical are delighted to announce we are now hiring a Radiopharmacy Qualified Person.
The role will involve planning, implementing, documenting, monitoring and further develop the Quality Assurance (QA) system.
Ensure every radiopharmaceutical product batch manufactured by Alliance Medical Ireland is tested and certified in compliance with GMP and HPRA guidelines before release to market.
Responsible for managing a small team, with early routine production times.
This role offers a full time, 37.5 hours per week, permanent contract.
Duties to Include: Responsible for the release of radiopharmaceutical products for distribution, ensuring full compliance with applicable regulations and guidelines.
Reviewing and approving batch documentation, analytical results, and all records associated with product manufacturing and testing.
Leading investigations into quality issues and deviations and implementing appropriate resolutions related to processes and materials.
Taking part in both internal and external audits of manufacturing sites and quality management systems.
Offering expert advice and support on regulatory requirements and quality standards to internal teams.
Participating in training as required (e.g. Radiation Safety).
Assist in developing and implementing standard operating procedures and training plans for the team.
Continuously recommend new processes to enhance operational effectiveness.
Support client Health Authority inspections, internal audit activities, and supplier audits, ensuring that any findings are resolved in a timely and satisfactory manner.
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.
Duties with Head of Quality Control: SOP/GMP document management, supplier/contractor oversight, specs validation support, staff training, etc.
Skills/Key Competencies Qualifications: Completed scientific university degree plus 3-5 year experience in GMP environment.
Qualified Person status or eligibility for QP status.
At least 3-5 years' experience in a quality management role in the Pharma industry Excellent communication and people skills.
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.