Thanduxolo Bonongo
Group Leader QC Lab at Aspen Pharma- Claim this Profile
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English Full professional proficiency
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Xhosa -
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Zulu Native or bilingual proficiency
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Sotho, Southern -
Topline Score
Bio
Credentials
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Chemistry
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Experience
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Aspen Pharma Australia
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Pharmaceutical Manufacturing
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500 - 600 Employee
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Group Leader QC Lab
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Sep 2017 - Present
Responsible for the QC Lab operations Responsible for the QC Lab operations
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Novartis
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Switzerland
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Pharmaceutical Manufacturing
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700 & Above Employee
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QC Supervisor
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Jun 2008 - Aug 2017
•I ensure QC department is compliant with official regulations, Health Authorities requirements and Novartis/Sandoz requirements. •I ensure adequate planning of routine lab testing (Raw Mats, Pack Mats) and plan according to Supply chain priorities. •Manage and place orders for reagents and consumables to ensure no delay on testing and release of products. •Investigate all lab OOS, OOE, OOT and Deviations on time and close of CAPS. •I ensure staff (QC Analyst and Samplers) are trained and training plans are updated yearly. •Assist QC manager in managing quality control in accordance with the cGMP regulations, current Good Laboratory Practices, Safety Procedures and Standard Operating Procedures. •Ensure calibration and maintenance of QC and IPC equipment is carried out at scheduled intervals. •Supervise and monitor the activities of QC where analyst perform physical and chemical testing of Raw Materials, Packaging Materials, Bulk and Finished products and Microbiological testing for raw materials, Pack Mats and finished products. •Supervise sampling of incoming Raw Materials, Packaging Materials, import Bulk is performed as per cGMP and on time as per priorities from Supply Chain. •Manage the QC sampling function in accordance with cGMP regulations, cGood QC Laboratory Practices, Safety Procedures and SOP's •Plan weekly activities on sampling and QC Lab. Monitor the completion of analysis by using SAP. •Review QC analytical raw data, Environmental Monitoring, Water Quality Monitoring, in accordance with QC requirements. •QC release/reject of tested incoming raw materials, packaging materials and bulk according to registered testing specifications. •Ensure SOP’s FRM’s and current test methods and PPM specification are in place. •Motivate QC personnel to work as a team and adhering to Novartis/Sandoz Quality behaviours. Show less
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Johnson & Johnson Health Care Systems Inc.
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United States
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Hospitals and Health Care
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300 - 400 Employee
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Senior Chemist
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Jul 2007 - May 2008
1. Analyzing correctly and accurately according to cGMP, and USP/NF/BP test in compliance with MCC rules & regulations, FDA, SOP, ISO 9002 – ISO 17025 to avoid repeats, rejects, product re-calls. 2. Analyzing finished goods products, in process, raw material, intermediates, bulk, stability, process validation and method validation. 3. Plan and co-ordinates work to ensure timorously analysis. Interpreting and compiling of analytical reports to PRISM and MAPS also generating raw data worksheets for chemist. 4. Perform and document investigations, including out of specification results. 5. Assist with training of chemist on GC and HPLC. 6. Perform troubleshooting, calibration and verification of lab instruments Techniques/ Instruments: Chromatographic and Spectrometric techniques. HPLC 1100, Alliance 2695, TLC, GC 6890, AA, FT-IR, UV/VIS, Polarimeter, Refractometer, Karl Fischer, Dissolution baths, DT, Viscometer and Autotitrators. Show less
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Pfizer
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United States
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Pharmaceutical Manufacturing
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700 & Above Employee
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Chemist
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Mar 2006 - Jun 2007
1. Analyzing correctly and accurately according to cGMP, and USP/NF/BP test in compliance with MCC rules & regulations, FDA, SOP, ISO 9002 – ISO 17025 to avoid repeats, rejects, product re-calls. 2. Analyzing finished goods products, in process, raw material, intermediates, bulk, stability, process validation and method validation. 3. Plan and co-ordinates work to ensure timorously analysis. Interpreting and compiling of analytical reports to PRISM and MAPS also generating raw data worksheets for chemist. 4. Perform and document investigations, including out of specification results. 5. Assist with training of chemist on GC and HPLC. 6. Perform troubleshooting, calibration and verification of lab instruments Techniques/ Instruments: Chromatographic and Spectrometric techniques. HPLC 1100, Alliance 2695, TLC, GC 6890, AA, FT-IR, UV/VIS, Polarimeter, Refractometer, Karl Fischer, Dissolution baths, DT, Viscometer and Autotitrators. Show less
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Vital Health Foods
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South Africa
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Wellness and Fitness Services
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100 - 200 Employee
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QC Analyst
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Sep 2005 - Mar 2006
Performing all testing correctly and accurately according to MCC, ISO 9002, 14000 And cGLP, cGMP, and USP/NF/BP. Performing finished goods testing, Vitamins, food & beverages, in process, stability and raw material. Interpretation and compiling Results. Performing and documenting investigations, including out of specification HPLC maintenance and SHE representative. Training laboratory analyst and performing calibration and verification of SOP’s for instruments. Performing instrument troubleshooting removing chemical waste generated in the Lab. Techniques/ Instruments: Chromatographic and Spectrometric techniques. (HPLC, TLC, GC, FTIR, NIR and UV/VIS spectrometry) Karl Fischer, Malvern Mastersizer and Autotitrators. Show less
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Fine chemicals
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Cape Town
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QC Analyst
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Jan 2004 - Sep 2005
Performing all testing correctly and accurately according to cGMP and cGLP. Performing swabbing analysis, finished goods testing, in-process, raw material, sampling and narcotics stock take. Review of all analyst notebooks. Performing all testing correctly and accurately according to cGMP and cGLP. Performing swabbing analysis, finished goods testing, in-process, raw material, sampling and narcotics stock take. Review of all analyst notebooks.
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Somchem
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Cape Town Area, South Africa
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QC Technician
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Jan 2002 - Dec 2003
• Performing all testing correctly and accurately of routine and non-routine analysis of Propellants, high explosive, and RDX, • Gravimetric and volumetric analysis. • Performing mechanical properties of propellants and base blinds analysis on Instron machine. • Finished goods testing, in-process, and raw materials. • Particle size distribution analysis. • Burning rates • Responsible for waste and delivering to the burning grounds. • Practices good housekeeping and adhering to safety and laboratory quality systems all the time. Show less
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Education
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1998 - 2001
Cape Peninsula University of Technology
ND Analytical Chemistry, Analytical Chemistry
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