
Lead QA Radiopharmacy
Job Description
The post holder will lead the Quality Assurance function for the Radiopharmacy Manufacturing Unit and will be responsible for ensuring compliance with Good Manufacturing Practice (GMP), MHRA licensing requirements and applicable quality standards. The post holder will act as a named Quality Controller on the MHRA Manufacturer's "Specials" Licence and will lead quality-related activities during regulatory inspections.
The role is responsible for maintaining and developing the Radiopharmacy Pharmaceutical Quality System, including oversight of standard operating procedures, quality risk management, audit programmes, validation activities, deviation investigations, corrective and preventive actions (CAPA), change control processes and continuous quality improvement initiatives. The post holder will ensure that facilities, equipment, processes and documentation remain compliant with regulatory requirements and industry best practice.
Working closely with the Chief and Deputy Chief Radiopharmacists, the post holder will contribute to the strategic development of Radiopharmacy services, support the implementation of new technologies and service developments, and provide specialist advice on quality, governance and regulatory matters. The post holder will also support the introduction and validation of new equipment, software systems and radiopharmaceutical services.
The post holder will lead and develop the Quality Assurance team, support workforce development and competency programmes, and contribute to the delivery of GMP training across the department. They will foster a culture of quality, compliance and continuous improvement and work collaboratively with colleagues across Radiopharmacy, Nuclear Medicine, Pharmacy and external organisations to ensure the continued provision of safe, effective and high-quality radiopharmacy services.
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