About the position
An exciting opportunity exists for a Junior QC Manager (Radiopharmaceuticals) with a company based in Johannesburg North.
The 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
Experience required
Quality control experience required 4 - 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
Qualifications
BSc / B.Tech or similar
Qualifications in radiopharmaceutical chemistry laboratory
Experience in 18F FDG Quality Control
Desired Skills:
- radioactive
- radiation
- radiopharmaceutical
- laboratory
- nuclear
- imaging agents
- radiochemistry
Employer & Job Benefits:
- Basic salary
- medical aid
- provident fund
