{"id":100502,"date":"2026-07-10T19:52:57","date_gmt":"2026-07-10T19:52:57","guid":{"rendered":"https:\/\/jobs.dataaxisnode.com\/kenya\/uncategorized\/consultant-qc-radio-pharmacist-nuclear-medicine\/"},"modified":"2026-07-10T19:52:57","modified_gmt":"2026-07-10T19:52:57","slug":"consultant-qc-radio-pharmacist-nuclear-medicine","status":"publish","type":"post","link":"https:\/\/jobs.dataaxisnode.com\/kenya\/jobs\/nairobi\/consultant-qc-radio-pharmacist-nuclear-medicine\/","title":{"rendered":"Consultant, QC Radio pharmacist, Nuclear Medicine"},"content":{"rendered":"<p><script type=\"application\/ld+json\">{\"@context\": \"https:\/\/schema.org\/\", \"@type\": \"JobPosting\", \"title\": \"Consultant, QC Radio pharmacist, Nuclear Medicine\", \"description\": \"Responsibilities:\\nIndependent QC Testing of Radiopharmaceuticals, Preparing and dispensing Radiopharmaceuticals.\\nPerform 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.\\nOperate and maintain HPLC, iTLC, dose calibrator, multi-channel analyser, endotoxin testing equipment.\\nConduct in-process controls during synthesis e.g., intermediate radiopurity checks on FASTlab.\\nPerform environmental monitoring testing settle plates, contact plates, active air sampling in Grade B\/C areas.\\nReview and verify Certificates of Analysis CoA for starting materials against approved specifications.\\nPerform stability testing of radiopharmaceutical preparations as per approved protocols.\\nBatch Documentation & Certificate of Analysis\\nPrepare and issue a Certificate of Analysis CoA for each manufactured batch documenting all QC results.\\nReview batch manufacturing records for completeness and accuracy prior to forwarding to QA for batch release.\\nMaintain controlled QC log books and electronic records in accordance with data integrity principles ALCOA+.\\nEnsure all out-of-specification OOS results are formally investigated and documented before any release decision.\\nEquipment Qualification & Method Validation\\nParticipate in Installation Qualification IQ, Operational Qualification OQ, and Performance Qualification PQ of QC equipment.\\nDevelop, validate, and verify analytical methods used for QC testing in alignment with Ph. Eur. \/ USP requirements.\\nMaintain calibration schedules and calibration records for all QC instruments.\\nEnsure QC equipment qualification documents are held on-site under QA control CAPA 3.3.\\nStarting Material & Supplier QC Oversight\\nVerify incoming starting materials 18O-enriched water, reagents, cassettes, vials, solvents, reference standards against written specifications.\\nPerform or coordinate testing of starting materials prior to release for use in manufacture.\\nMaintain a material control system including receipt, testing, quarantine, approval, and rejection procedures CAPA 2.4b.\\nLabelling Verification\\nVerify 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.\\nPerform label reconciliation and maintain labelling records for each batch.\\nEnvironmental Monitoring & Aseptic Assurance\\nExecute the environmental monitoring EM programme including viable and non-viable particulate monitoring in classified areas.\\nInterpret EM data, identify trends, and report exceedances to the QA Radiopharmacist.\\nConduct media fill process simulation testing as per aseptic processing guidelines.\\nQC Training & Continuous Improvement\\nProvide training to Nuclear Medicine Technologists on in-process QC procedures and documentation requirements.\\nParticipate in GMP training programmes and internal\/external audits.\\nSupport implementation of QRM exercises pertaining to QC processes CAPA 2.1.\\nStay current with pharmacopoeial updates Ph. Eur., USP relevant to radiopharmaceutical QC.\\nIndependence and Segregation of Duties\\nThe 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 \u00a75; EANM cGRPP \u00a74.2.\\nThe QC Radiopharmacist shall not certify or release batches \u2013 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.\\nQC laboratory space, instruments, and consumables shall be dedicated and physically separated from the production area where practicable.\\nThe QC Radiopharmacist reports to the QA Radiopharmacist and administratively to the Section Head, Nuclear Medicine \u2013 NOT to the Production Supervisor or Lead Technologist.\\nRequirements:\\nBachelor of Pharmacy BPharm \u2013 mandatory; registered with the Pharmacy and Poisons Board of Kenya.\\nPost-graduate Diploma or master\u2019s degree in Radiopharmacy or Pharmaceutical Sciences \u2013 strongly desirable.\\nFormal training in GMP for Radiopharmaceuticals WHO, IAEA, or EANM accredited course \u2013 mandatory within 6 months of appointment.\\nValid Basic Life Support BLS certificate.\\nTraining in radiation safety and radiation protection principles \u2013 mandatory.\\nMinimum 2 years' experience in a Radio pharmacy QC.\\nPractical experience with radiopharmaceutical QC techniques: iTLC, HPLC, dose calibrator, endotoxin testing.\\nExperience with GMP documentation systems batch records, deviation reports, CAPA, change control.\\nExperience with aseptic processi\", \"datePosted\": \"2026-07-09\", \"hiringOrganization\": {\"@type\": \"Organization\", \"name\": \"Aga Khan University Hospital\"}, \"jobLocation\": {\"@type\": \"Place\", \"address\": {\"@type\": \"PostalAddress\", \"addressLocality\": \"Nairobi\", \"addressCountry\": \"KE\"}}, \"directApply\": true, \"validThrough\": \"2026-07-23T23:59:59\", \"employmentType\": \"FULL_TIME\"}<\/script><\/p>\n<p><strong>Company:<\/strong> Aga Khan University Hospital<\/p>\n<p><strong>Location:<\/strong> Nairobi<\/p>\n<p><strong>Job Type:<\/strong> Full Time<\/p>\n<p><strong>Apply Before:<\/strong> 2026-07-23<\/p>\n<h3>Job Description<\/h3>\n<p>Responsibilities:<br \/>Independent QC Testing of Radiopharmaceuticals, Preparing and dispensing Radiopharmaceuticals.<br \/>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.<br \/>Operate and maintain HPLC, iTLC, dose calibrator, multi-channel analyser, endotoxin testing equipment.<br \/>Conduct in-process controls during synthesis e.g., intermediate radiopurity checks on FASTlab.<br \/>Perform environmental monitoring testing settle plates, contact plates, active air sampling in Grade B\/C areas.<br \/>Review and verify Certificates of Analysis CoA for starting materials against approved specifications.<br \/>Perform stability testing of radiopharmaceutical preparations as per approved protocols.<br \/>Batch Documentation &#038; Certificate of Analysis<br \/>Prepare and issue a Certificate of Analysis CoA for each manufactured batch documenting all QC results.<br \/>Review batch manufacturing records for completeness and accuracy prior to forwarding to QA for batch release.<br \/>Maintain controlled QC log books and electronic records in accordance with data integrity principles ALCOA+.<br \/>Ensure all out-of-specification OOS results are formally investigated and documented before any release decision.<br \/>Equipment Qualification &#038; Method Validation<br \/>Participate in Installation Qualification IQ, Operational Qualification OQ, and Performance Qualification PQ of QC equipment.<br \/>Develop, validate, and verify analytical methods used for QC testing in alignment with Ph. Eur. \/ USP requirements.<br \/>Maintain calibration schedules and calibration records for all QC instruments.<br \/>Ensure QC equipment qualification documents are held on-site under QA control CAPA 3.3.<br \/>Starting Material &#038; Supplier QC Oversight<br \/>Verify incoming starting materials 18O-enriched water, reagents, cassettes, vials, solvents, reference standards against written specifications.<br \/>Perform or coordinate testing of starting materials prior to release for use in manufacture.<br \/>Maintain a material control system including receipt, testing, quarantine, approval, and rejection procedures CAPA 2.4b.<br \/>Labelling Verification<br \/>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.<br \/>Perform label reconciliation and maintain labelling records for each batch.<br \/>Environmental Monitoring &#038; Aseptic Assurance<br \/>Execute the environmental monitoring EM programme including viable and non-viable particulate monitoring in classified areas.<br \/>Interpret EM data, identify trends, and report exceedances to the QA Radiopharmacist.<br \/>Conduct media fill process simulation testing as per aseptic processing guidelines.<br \/>QC Training &#038; Continuous Improvement<br \/>Provide training to Nuclear Medicine Technologists on in-process QC procedures and documentation requirements.<br \/>Participate in GMP training programmes and internal\/external audits.<br \/>Support implementation of QRM exercises pertaining to QC processes CAPA 2.1.<br \/>Stay current with pharmacopoeial updates Ph. Eur., USP relevant to radiopharmaceutical QC.<br \/>Independence and Segregation of Duties<br \/>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 \u00a75; EANM cGRPP \u00a74.2.<br \/>The QC Radiopharmacist shall not certify or release batches \u2013 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.<br \/>QC laboratory space, instruments, and consumables shall be dedicated and physically separated from the production area where practicable.<br \/>The QC Radiopharmacist reports to the QA Radiopharmacist and administratively to the Section Head, Nuclear Medicine \u2013 NOT to the Production Supervisor or Lead Technologist.<br \/>Requirements:<br \/>Bachelor of Pharmacy BPharm \u2013 mandatory; registered with the Pharmacy and Poisons Board of Kenya.<br \/>Post-graduate Diploma or master\u2019s degree in Radiopharmacy or Pharmaceutical Sciences \u2013 strongly desirable.<br \/>Formal training in GMP for Radiopharmaceuticals WHO, IAEA, or EANM accredited course \u2013 mandatory within 6 months of appointment.<br \/>Valid Basic Life Support BLS certificate.<br \/>Training in radiation safety and radiation protection principles \u2013 mandatory.<br \/>Minimum 2 years&#8217; experience in a Radio pharmacy QC.<br \/>Practical experience with radiopharmaceutical QC techniques: iTLC, HPLC, dose calibrator, endotoxin testing.<br \/>Experience with GMP documentation systems batch records, deviation reports, CAPA, change control.<br \/>Experience with aseptic processing and environmental monitoring \u2013 desirable.<br \/>Familiarity with Ph. Eur. or USP monographs for radiopharmaceuticals e.g., [18F]FDG, [68Ga]-labelled agents, [18F]PSMA.<br \/>High attention to detail and commitment to data integrity ALCOA+ principles.<br \/>Strong analytical and problem-solving skills; ability to conduct OOS investigations.<br \/>Excellent written and oral communication skills for documentation and reporting.<br \/>Ability to work independently and make objective, evidence-based decisions under time pressure.<br \/>Thorough understanding of GMP principles, QC independence, and regulatory compliance.<br \/>Proficiency in laboratory data management systems and spreadsheet software.<br \/>Strong interpersonal skills; collaborative team member within a multidisciplinary setting.<br \/>Commitment to continuous learning and professional development.<\/p>\n<h3>How to Apply<\/h3>\n<p>Interested and qualified? Go to Aga Khan University Hospital on aku.taleo.net to apply<br \/>Build your CV for free. Download in different templates.<\/p>\n<p><a href=\"https:\/\/www.myjobmag.co.ke\/apply-now\/1274151\" target=\"_blank\" rel=\"noopener\" style=\"display:inline-block;padding:10px 20px;background:#2271b1;color:#fff;text-decoration:none;border-radius:4px;\">Apply Now<\/a><\/p>\n<p><small>Source: MyJobMag<\/small><\/p>\n<p><!-- job-expiry: 2026-07-23 --><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Company: Aga Khan University Hospital Location: Nairobi Job Type: Full Time Apply Before: 2026-07-23 Job Description 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 [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_feature_clip_id":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_post_was_ever_published":false},"categories":[1408,1409],"tags":[1473,1425,1413,1412],"class_list":["post-100502","post","type-post","status-publish","format-standard","hentry","category-jobs","category-nairobi","tag-aga-khan-university-hospital","tag-full-time","tag-job-listing","tag-myjobmag"],"jetpack_featured_media_url":"","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/jobs.dataaxisnode.com\/kenya\/wp-json\/wp\/v2\/posts\/100502","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/jobs.dataaxisnode.com\/kenya\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/jobs.dataaxisnode.com\/kenya\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/jobs.dataaxisnode.com\/kenya\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/jobs.dataaxisnode.com\/kenya\/wp-json\/wp\/v2\/comments?post=100502"}],"version-history":[{"count":0,"href":"https:\/\/jobs.dataaxisnode.com\/kenya\/wp-json\/wp\/v2\/posts\/100502\/revisions"}],"wp:attachment":[{"href":"https:\/\/jobs.dataaxisnode.com\/kenya\/wp-json\/wp\/v2\/media?parent=100502"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/jobs.dataaxisnode.com\/kenya\/wp-json\/wp\/v2\/categories?post=100502"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/jobs.dataaxisnode.com\/kenya\/wp-json\/wp\/v2\/tags?post=100502"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}