Responsibilities:
Independent QC Testing of Radiopharmaceuticals, Preparing and dispensing Radiopharmaceuticals.
Perform all mandatory QC tests on radiopharmaceutical preparations before batch release, including: radionuclidic identity and purity, radiochemical purity (iTLC/HPLC), chemical purity, pH, visual inspection, sterility, endotoxin/pyrogen, and residual solvent testing per Ph. Eur. / USP monographs.
Operate and maintain HPLC, iTLC, dose calibrator, multi-channel analyser, endotoxin testing equipment.
Conduct in-process controls during synthesis (e.g., intermediate radiopurity checks on FASTlab).
Perform environmental monitoring testing (settle plates, contact plates, active air sampling) in Grade B/C areas.
Review and verify Certificates of Analysis (CoA) for starting materials against approved specifications.
Perform stability testing of radiopharmaceutical preparations as per approved protocols.
Batch Documentation & Certificate of Analysis
Prepare and issue a Certificate of Analysis (CoA) for each manufactured batch documenting all QC results.
Review batch manufacturing records for completeness and accuracy prior to forwarding to QA for batch release.
Maintain controlled QC log books and electronic records in accordance with data integrity principles (ALCOA+).
Ensure all out-of-specification (OOS) results are formally investigated and documented before any release decision.
Equipment Qualification & Method Validation
Participate in Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of QC equipment.
Develop, validate, and verify analytical methods used for QC testing in alignment with Ph. Eur. / USP requirements.
Maintain calibration schedules and calibration records for all QC instruments.
Ensure QC equipment qualification documents are held on-site under QA control (CAPA 3.3).
Starting Material & Supplier QC Oversight
Verify incoming starting materials (18O-enriched water, reagents, cassettes, vials, solvents, reference standards) against written specifications.
Perform or coordinate testing of starting materials prior to release for use in manufacture.
Maintain a material control system including receipt, testing, quarantine, approval, and rejection procedures (CAPA 2.4b).
Labelling Verification
Verify that primary packaging labels for all finished radiopharmaceutical preparations comply with IAEA guidelines and PPB requirements (CAPA 3.4), including: product name, radionuclide, batch number, activity at calibration time, calibration time, expiry, route of administration, storage conditions, manufacturer details.
Perform label reconciliation and maintain labelling records for each batch.
Environmental Monitoring & Aseptic Assurance
Execute the environmental monitoring (EM) programme including viable and non-viable particulate monitoring in classified areas.
Interpret EM data, identify trends, and report exceedances to the QA Radiopharmacist.
Conduct media fill (process simulation) testing as per aseptic processing guidelines.
QC Training & Continuous Improvement
Provide training to Nuclear Medicine Technologists on in-process QC procedures and documentation requirements.
Participate in GMP training programmes and internal/external audits.
Support implementation of QRM exercises pertaining to QC processes (CAPA 2.1).
Stay current with pharmacopoeial updates (Ph. Eur., USP) relevant to radiopharmaceutical QC.
Independence and Segregation of Duties
The QC Radiopharmacist shall at no time be involved in, or subordinate to, the Production function. All QC decisions shall be made independently of production personnel (WHO TRS 1025 §5; EANM cGRPP §4.2).
The QC Radiopharmacist shall not certify or release batches - batch certification and release is reserved exclusively for the QA Radiopharmacist (Authorised Person/Company Pharmacist). The QC Radiopharmacist provides the completed QC dossier and CoA to QA as the input to the release decision.
QC laboratory space, instruments, and consumables shall be dedicated and physically separated from the production area where practicable.
The QC Radiopharmacist reports to the QA Radiopharmacist and administratively to the Section Head, Nuclear Medicine - NOT to the Production Supervisor or Lead Technologist.
Requirements:
Bachelor of Pharmacy (BPharm) - mandatory; registered with the Pharmacy and Poisons Board of Kenya.
Post-graduate Diploma or master's degree in Radiopharmacy or Pharmaceutical Sciences - strongly desirable.
Formal training in GMP for Radiopharmaceuticals (WHO, IAEA, or EANM accredited course) - mandatory within 6 months of appointment.
Valid Basic Life Support (BLS) certificate.
Training in radiation safety and radiation protection principles - mandatory.
Minimum 2 years' experience in a Radio pharmacy QC.
Practical experience with radiopharmaceutical QC techniques: iTLC, HPLC, dose calibrator, endotoxin testing.
Experience with GMP documentation systems (batch records, deviation reports, CAPA, change control).
Experience with aseptic processing and environmental monitoring - desirable.
Familiarity with Ph. Eur. or USP monographs for radiopharmaceuticals (e.g., [18F]FDG, [68Ga]-labelled agents, [18F]PSMA).
High attention to detail and commitment to data integrity (ALCOA+ principles).
Strong analytical and problem-solving skills; ability to conduct OOS investigations.
Excellent written and oral communication skills for documentation and reporting.
Ability to work independently and make objective, evidence-based decisions under time pressure.
Thorough understanding of GMP principles, QC independence, and regulatory compliance.
Proficiency in laboratory data management systems and spreadsheet software.
Strong interpersonal skills; collaborative team member within a multidisciplinary setting.
Commitment to continuous learning and professional development.