Kabelo Sekwele

Experienced Pharmaceutical Microbiologist with 10+ years of Quality Control experience in a GMP-regulated pharmaceutical environment. Skilled in microbiological testing, environmental monitoring, OOS/OOT investigations and data integrity with experience training and mentoring microbiologists and laboratory personnel. Seeking to leverage extensive pharmaceutical microbiology expertise and growing Quality Assurance knowledge in a Senior QC Microbiologist or QA/QC Specialist role.

Microbiologist at Adcock Ingram Healthcare (2015-10 – Present)

• Perform analysis of raw materials, in-process bulk, finished products and third party samples according to specifications
• Conduct accurate and timely microbiological testing to support product release and production schedules
• Reporting of any OOS to microbiology supervisor and assist with OOS investigations
• Perform purified water and Water for Injection (WFI) testing, including microbiological and bacterial endotoxin testing in accordance with applicable EP and USP requirements
• Validation of purified and potable water using EP and USP methods
• Perform and trend environmental monitoring within controlled pharmaceutical manufacturing environments
• Conduct microbiological testing associated with sterility, bioburden and microbial limits as applicable to laboratory requirements
• Media preparation, pH, sterility and growth promotion tests
• Maintenance, control and verification of microbiological cultures (E.Coli, S.typhimurium, S.aureus, B.spizizenni, P.aeruginosa, C.albicans, A.brasiliensis, in-house flora)
• Identification of microorganisms using VITEK2 Compact
• Execution of side studies (e.g media shelf life, disinfectant efficacy) according to approved validation protocols
• Work collaboratively with cross-functional teams while maintaining a high level of attention to detail and compliance
• Support the qualification of new laboratory instruments and equipment
• Maintenance of laboratory equipments, supplies, and to ensure effective testing
• Perform sterility verification tests on sterile facility garments, gloves, googles and other applicable materials
• Train and mentor new microbiologists and graduates, including assessment of competency against applicable laboratory requirements
• Assist with laboratory work planning and allocation of activities to ensure testing is completed within required timelines
• Maintain compliance with GMP, GLP, SOPs and Quality Management System requirements
• Apply data integrity principles, including appropriate documentation, traceability and accurate recording of laboratory data

Temporary Microbiologist at Adcock Ingram Healthcare (2013-07 – 2014-02)

• Perform microbiological testing of samples according to test methods
• Perform testing of potable and purified water (pH, Conductivity, E.Coli, P. aeruginosa, Coliforms)
• Perform environmental monitoring in production areas
• Media preparation and growth promotion testing
• Monitoring of temperatures and humidity of rooms and instruments
• Operations and maintenance of laboratory equipments
• Adhering to good laboratory practices

Junior Laboratory Assistant at University of Limpopo (2011-06 – 2012-03)

• Demonstrating for students during practicals
• Marking of practical test papers
• Assisting with laboratory cleanup and housekeeping after practicals
• Preparation of media and set-up of materials for students
• Autoclaving of waste and washing of glassware used for practicals

Bachelor of Science in Microbiology, Zoology – University of Limpopo (2009)

Grade 12 – Manoka High School (2005)