Role Overview
Aga Khan University Hospital is seeking a Consultant, QC Radio Pharmacist, Nuclear Medicine to be based in Nairobi. The role involves performing independent quality control (QC) testing of radiopharmaceuticals, preparing and dispensing radiopharmaceuticals, and ensuring strict compliance with Good Manufacturing Practices (GMP), radiation safety regulations, and professional standards.
Key Responsibilities
Independent QC Testing & Preparation of 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, and 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.
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 use in manufacture.
- Maintain a material control system including receipt, testing, quarantine, approval, and rejection procedures.
Labelling Verification
- Verify that primary packaging labels for all finished radiopharmaceutical preparations comply with IAEA guidelines and PPB requirements, including: product name, radionuclide, batch number, activity at calibration time, calibration time, expiry, route of administration, storage conditions, and 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.
- Stay current with pharmacopoeial updates (Ph. Eur., USP) relevant to radiopharmaceutical QC.
Independence and Segregation of Duties
- Ensure the QC Radiopharmacist is at no time involved in, or subordinate to, the Production function. All QC decisions must be made independently of production personnel.
- The QC Radiopharmacist shall not certify or release batches – batch certification and release is reserved exclusively for the QA Radiopharmacist.
- Ensure QC laboratory space, instruments, and consumables are dedicated and physically separated from the production area where practicable.
- Report to the QA Radiopharmacist and administratively to the Section Head, Nuclear Medicine.
