Duties and responsibilities

• Implement, troubleshoot and manage the microbiological testing methods including equipment for testing biological medicines according to ISO 17025, WHO and GMP requirements.
• Training and supervision of staff in the microbiological section.
• Perform the necessary laboratory testing on biological medicines including data capture and verification.
• Perform the necessary QC management associated with microbiological and biological medicines testing.
• Plan and perform the environmental microbiological monitoring.
• Perform reviews of biological product manufacturing protocols.

Inherent Job Requirements:

• MSc on NQF level 9 in a Biological Sciences related field.
• A minimum of two (2) years’ practical experience in Microbiological culture methods.

Recommendations:

• Experience in working in an ISO 17025 accredited, GMP licensed or similarly regulated environment.
• Knowledge of the relevant guidance documents related to the testing and control and regulation of biological medicines and vaccines, these include documents published by the SAHPRA, WHO, EDQM, CHMP and ICH.
• Practical experience in one or more of the following technologies:
• Environmental Microbiological Monitoring.
• High performance liquid chromatography (HPLC).
• lmmunochemistry assays (e.g., ELISA, Rate Nephelometry, SRID).
• Real time quantitative polymerase chain reaction (qPCR).
• Endotoxin testing by Chromogenic Kinetic Method.
• The application of statistical models for the analysis of data.