Quality Control & GMP Specialist – Radiopharmaceuticals
Full-time | On-site | 2-year Fixed Term | London (Hospital-based)
Summary

This role supports the setup, implementation, and ongoing GMP compliance of a radiopharmaceutical QC laboratory. Responsibilities include analytical testing, quality system oversight, documentation control, and ensuring adherence to GMP/GLP standards.
Key Responsibilities
GMP & Quality Compliance
*Review production and analytical processes for GMP and regulatory compliance.
*Maintain and update SOPs, documentation, and quality records.
*Support investigations, deviations, OOS, CAPA, change controls, and material release.
*Review QC and microbiology results, managing non-compliances.
*Support audits, data integrity checks, and validation documentation.
Quality Systems & Governance
*Review equipment, storage, and QC logs.
*Lead or support root cause analysis and CAPA development.
*Contribute to day-to-day QA operations and GMP governance.
*Support batch release processes and audit readiness.
QC Laboratory Activities
*Perform QC testing in line with EP/SmPC requirements.
*Interpret and record analytical data, escalating issues as required.
*Maintain logbooks, data integrity, consumable stock levels, and equipment calibration.
*Lead or support validation planning and execution.
Training & Support
*Train technicians in QC testing for SPECT and PET products across UK sites.
Requirements
Education & Experience
*Degree in a relevant scientific field.
*2–3 years’ radiopharmacy QC experience.
Knowledge & Skills
*Strong understanding of GMP and pharmaceutical chemistry.
*Effective communicator and team player.
*High attention to detail, strong time management, practical laboratory ability.
*Ability to work shifts.
*Radiation knowledge desirable.