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.