BioTalent are supporting a global leader in the development, manufacture, and distribution of innovative radiopharmaceutical products used in advanced diagnostic imaging and targeted therapies. With decades of industry expertise and international operations, they support millions of patients each year through high-quality, life-enhancing medicines.
Our organization operates within highly regulated healthcare environments and is committed to innovation, operational excellence, and the highest standards of quality and patient safety.
The Role
We are seeking a Senior QA Specialist to design and implement analytical testing processes for radiopharmaceutical products while ensuring the QC Laboratory remains fully compliant with GMP and GLP standards. This is a hands-on, site-based role combining Quality Assurance oversight with active involvement in Quality Control activities.
Key Responsibilities
* Ensure production and analytical methods comply with GMP guidelines, pharmacopoeial standards (EP/BP), and product specifications.
* Maintain and support the Quality Management System (QMS), including Deviations, OOS, CAPA, Change Control, Complaints, Recalls, Risk Assessments, Supplier Approval, and Validation documentation.
* Review and approve QC analytical and microbiological results; manage investigations and ensure data integrity compliance.
* Perform and oversee QC testing of radiopharmaceutical products in line with regulatory and internal standards.
* Lead or support root cause investigations and implement effective corrective and preventive actions (CAPA).
* Maintain laboratory documentation, logbooks, validation master plan (VMP), equipment calibration schedules, and stock control.
* Support batch release activities, audit readiness, and regulatory inspections.
* Train technicians in SPECT and PET QC analytical testing across UK sites.
* Support the QA Manager with day-to-day quality oversight and continuous improvement initiatives.
Education & Experience
* Degree in a related scientific discipline.
* 2–3 years’ experience in radiopharmacy Quality Control.
* Working knowledge of pharmaceutical chemistry and Good Manufacturing Practice (GMP).
* Knowledge of radiation safety principles (desirable).
Skills & Competencies
* Strong attention to detail and practical laboratory skills.
* Excellent communication and teamwork abilities.
* Ability to work under pressure and manage priorities effectively.
* Good customer-facing skills and professional conduct.
* Basic computer literacy and strong time management.
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