Consultant, QC Radio pharmacist, Nuclear Medicine Job AKUH

AI summary

Aga Khan University Hospital in Nairobi is hiring a Consultant, QC Radiopharmacist for Nuclear Medicine. The role involves independent QC testing, dispensing radiopharmaceuticals, and ensuring GMP compliance at the AKUHN Tracer Centre. Formal training in GMP for Radiopharmaceuticals is required.

• Works at AKUHN Tracer Centre in Nairobi
• Must have formal training in GMP for Radiopharmaceuticals
• Responsible for batch release QC testing
• Full-time middle-level position

Description

Job Title: Consultant, QC Radio pharmacist, Nuclear Medicine Date Posted: 09/07/2026 Job Type: Full Time Job Level: Middle Employer: Aga Khan University Hospital Industry: Medical Salary: Open Location: Nairobi Country: Kenya Deadline: 23/07/2026 Summary: Looking for a medical job in Kenya? Aga Khan University Hospital is hiring a Consultant, QC Radiopharmacist – Nuclear Medicine to ensure compliance with safety and regulatory standards. The role is based in Nairobi and formal training in GMP for Radiopharmaceuticals required. The incumbent will be responsible for the independent analytical testing, in-process and finished-product quality control, dispensing radiopharmaceuticals, maintaining GMP documentation practices and release support for all radiopharmaceuticals manufactured at the AKUHN Tracer Centre. The role ensures that no radiopharmaceutical batch is released for patient administration without satisfactory completion of all prescribed QC tests in accordance with applicable pharmacopeial standards, WHO Technical Report Series (TRS) 1025 Annex 2, IAEA Safety Standards Series SSG-44, and EANM Radiopharmacy Committee guidelines. Must at all times maintain strict independence from production activities as required by GMP principles. Key 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. Qualifications 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 cours