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Radiopharmacy quality assurance manager (qualified person)

Dublin
Alliance Medical Diagnostic Imaging Ltd
Qa manager
Posted: 11h ago
Offer description

Alliance Medical are delighted to announce we are now hiring a Radiopharmacy Quality Assurance Manager (Qualified Person). We are seeking QA Manager to lead our QA team and play a pivotal role in safeguarding product quality, patient safety, and regulatory compliance. This role offers a full time, 37.5 hours per week, permanent contract. Overall Purpose: Plan, implement, document, monitor and further develop the Quality Assurance (QA) system. Ensure every 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. Duties to Include: Coordinate and lead all QA activities and regularly review and implement laws, regulations and GMP guidelines into the QA system. Participating in training as required (e.g. Leadership & Management, Radiation Safety and Qualified Person courses). 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 for facility inspections. Ensure batch certification and release processes are followed. Maintain the release register including recalls and oversee storage for retained samples. Responsible for the hiring and management of an engaged and motivated team, effectively utilizing 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. Continuously 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. Lead investigations, quality events & drive effective CAPA closure. Be responsible for radiation safety responsibilities as required. Duties with Head of Quality Control & Qualified Persons: 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. 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. #amdi To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process, click the Apply button below to Login/Register.

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