Quality Control Technician/Manager, Nuclear Medicine, MedTech | Gauteng

Reporting This position will report to the Responsible Pharmacist and Quality Assurance Manager The candidate is required to reside in Johannesburg or Pretoria. The candidate will be working in a Radiation environment. Area of Responsibility Quality Control Manager to complete and oversee routine testing and analysis for the laboratory including the production of standard 18F synthesis and other tracers in strict adherence to Good Manufacturing Practices (GMP), relevant European Union (EU) and United states (USP) pharmacopoeia standards. Manage raw material sampling, testing and release system. Ensure efficient performance of, and undertake first-line maintenance of, Quality Control equipment including: - High Performance Liquid Chromatography (HPLC), Chromatography (radiochemical and chemical purity of 18F FDG) , Gas Chromatography, pH measurement, Radio Thin Layer Chromatography (RTLC), Gamma Spectrometer Limulus Amoebocyte Lysate (LAL) testing. Maintain records of faults, maintenance, and calibration on any dysfunction, operation or equipment. In association with the RP and Quality Assurance team to develop, implement and manage cGMP, Quality Control and Quality Assurance systems and procedures for standard tracers. Management of QC raw material and consumables, formulation of reagents for radiochemistry, mixing of solvents for HPLC and other analyses, cleaning of glassware and disposal of waste chemicals and materials. Prepare updated SOPs in accordance with the relevant guidelines as may be necessary from time to time for approval by the RP and adoption by the group. Provide training and support for others selected as backup in undertaking routine QC operations. Maintain understanding of best practice and changes in requirements for QC analytical testing. Undertake training as a Radiation Protection officer (RPO) to safely undertake the routine manufacturing of radiopharmaceuticals and the disposal of radioactive waste. Strictly adhere to GMP, Good Laboratory Practice (GLP) and safety protocols laid down by SAHPRA, in accordance with issued licenses as determined by Quality assurance pharmacist time to time. Corresponding and adherence to local rules developed to ensure conformity to such licensing requirements Requirements Qualifications BSc Chemistry or higher Qualifications in radiopharmaceutical chemistry laboratory Experience in 18F FDG Quality Control Experience required Quality control experience required 5 years Managerial experience will be advantageous Skills and Competencies Working effectively with members of the team Excellent interpersonal skills Excellent organisational skills Attention to detail Good listening skills Self-motivated Able to work independently and effectively by completing tasks in a timely manner #LI-KT1 Benefits Basic Salary 50% medical aid and Provident Fund contribution. #LI-KT1