Bradley Mapfumo Email & Phone Number

Sydney, Nsw, Au

Sydney, Nsw, Au

Australia

• Conducting microbiological testing in accordance with approved procedures.• Assisting in setting up Microbiology and PC2 laboratory.• Equipment qualification including IQ, OQ and PQ.• Standard routine tests on products, materials, and generating laboratory results, using a range of analytical and microbial techniques such as sterility, isolator, endotoxin and bioburden testing.• Environmental monitoring of the production facility, including viable, non-viable and… Show more • Conducting microbiological testing in accordance with approved procedures.• Assisting in setting up Microbiology and PC2 laboratory.• Equipment qualification including IQ, OQ and PQ.• Standard routine tests on products, materials, and generating laboratory results, using a range of analytical and microbial techniques such as sterility, isolator, endotoxin and bioburden testing.• Environmental monitoring of the production facility, including viable, non-viable and utilities testing such as water and compressed gas sampling.• Checking of assays, result entry and verification of assay paperwork.• Ensuring that safe environment is maintained at all times• Maintenance of QC documentation and training records.• Ensuring all samples in the QC laboratory are documented as per approved procedures• Updating and reviewing documentation (SOP’s, Test methods, Work Instructions and Specifications)• Assisting in validation and qualification of microbiological test methods and equipment qualification• Supporting the team to ensure that the testing performed in each department is prepared and executed in accordance with GMP• Root cause analysis and implementing CAPA.• Calibrating and maintaining laboratory equipment• Ordering and maintaining stock of reagents, consumables • Method development and validation of test methods• Handling of Investigations and Deviations• Assisting in training when required• Being a part of Regulatory and Internal audits Show less

Harare, Zimbabwe

• Microbiological testing of raw materials, in-process samples, finished products and stability samples to achieve QC standards• Developing and reviewing Standard Operating Procedures (SOPs)• Training employees on sterility of cleanrooms according to Annex 1 EU GMP• Aseptic sampling of raw materials and finished products for microbiological testing and release•Purified water testing including total bacterial count, total coliforms and absence of Pseudomonas aeruginosa… Show more • Microbiological testing of raw materials, in-process samples, finished products and stability samples to achieve QC standards• Developing and reviewing Standard Operating Procedures (SOPs)• Training employees on sterility of cleanrooms according to Annex 1 EU GMP• Aseptic sampling of raw materials and finished products for microbiological testing and release•Purified water testing including total bacterial count, total coliforms and absence of Pseudomonas aeruginosa •Environmental monitoring of clean rooms for viable and non-viable particles•General contamination tests and identification of microorganisms using several techniques such as macroscopic, microscopic, gram staining and microscopy, biochemical assays, PCR and Immunoassays.•Preservative ability/efficiency testing•Efficiency testing of disinfectants•Speciation of bacteria and fungi/moulds (Pseudomonas aeruginosa, Staphylococcus aureus, Escherichia coli, Salmonella, Candida albicans)•Use of PCR if culturing and Immunoassays cannot be used to identify microorganisms •Bioburden testing, sterility testing and microbial limit testing of consumables and raw materials used in cleanrooms or aseptic compounding units•Using gel clot technique for bacterial endotoxin testing of gram negative bacteria •Drain trap analysis, compressed air analysis, personnel hand swabs, equipment swabs and growth promotion testing •Purified water quality failure/incident investigation•Trending of data•Equipment calibration and servicing •Preparation and storage of culture media as well as control and maintenance of stock cultures •Carrying out Corrective Action Preventative Action (CAPA) and deviation handling •USP, BP and Pharmacopeia usage•Documentation for data integrity •Validation of microbiological test methods •Use of bio-indicators •Performing USP 788 Microscopy and Staining •Selective agar identification•Maintaining the Microbiology Laboratory ready for audits and inspections Show less

Harare, Zimbabwe

• Microbial analysis of water beverages• Swabbing and testing of manufacturing surfaces and equipment • Personnel swabs on food handlers and testing • Environmental monitoring of production air using settle plates • Plate reading and speciation of microorganisms found upon performing several Microbial test methods like bioburden and sterility testing• Total coliforms and total aerobic bacterial count testing of purified water from Reverse Osmosis plant• Gram staining… Show more • Microbial analysis of water beverages• Swabbing and testing of manufacturing surfaces and equipment • Personnel swabs on food handlers and testing • Environmental monitoring of production air using settle plates • Plate reading and speciation of microorganisms found upon performing several Microbial test methods like bioburden and sterility testing• Total coliforms and total aerobic bacterial count testing of purified water from Reverse Osmosis plant• Gram staining, microscopy and bacterial endotoxin testing• Conducted online quality checks of beverages including brix and carbon dioxide values on canning lines and bottling lines• Performed quality checks on beverage packaging including cans and polyethylene terephthalate bottles• Use and calibration of laboratory equipment (Saccharimeter, Carbon dioxide meter, spectrometer, digital pH meter, density and sound velocity meter, polyethylene terephthalate packaging pressure tester• Calibration, validation and operation of production line equipment• Reagent preparation for laboratory and in-line quality checks• Performed out of process capability studies on bottling lines (Generation of capability indices)• Monitoring and analysis of production line process input and output management systems• Inspection of production line maintenance cleaning and sanitisation• Sensory evaluation of beverage syrups, final beverages and treated water• Facilitation of team problem solving and root cause analysis of consumer complaints and non-conforming products• Conducted internal audits on Quality Management, Food Safety and Occupational Health and Safety Show less

Bulawayo, Zimbabwe

•Sampling of raw materials according to Standard Operating Procedures (SOPs)•Carried out microbiological analysis and SOP-prescribed assays on raw materials, in-process products and finished products• Microbiological testing of raw materials, in-process samples, finished products and stability study samples to achieve QC standards• Purified water testing (total bacterial count test, total coliforms test and the absence of Pseudomonas aeruginosa test)• Environmental monitoring of… Show more •Sampling of raw materials according to Standard Operating Procedures (SOPs)•Carried out microbiological analysis and SOP-prescribed assays on raw materials, in-process products and finished products• Microbiological testing of raw materials, in-process samples, finished products and stability study samples to achieve QC standards• Purified water testing (total bacterial count test, total coliforms test and the absence of Pseudomonas aeruginosa test)• Environmental monitoring of aseptic cleanrooms investigating air, surface, personnel and point of use purified water • Bioburden control of raw materials and other consumables used in aseptic manufacturing rooms• General contamination analysis of stability study samples like Return On Going, Market-Related and Accelerated stabilty• Contamination tests and identification of microorganisms using macroscopic techniques, microscopic techniques, PCR and Immunoassays • Drain trap analysis, disinfectant efficacy testing and microbial limit testing in cleanrooms• Sterility testing in cleanrooms with focus on HVAC, gowning, behaviour, bioburden control and cleaning/disinfection• Examining of packaging materials and other goods received• Good documentation practice and trending of environmental monitoring data• Performed Microbiological method validation• Ensured compliance of production staff to current Good Manufacturing Practices (cGMP)• Trained interns on GMP, Safety, Health and Environmental management (SHE) and how to use and calibrate laboratory equipment• Identification of bacterial endotoxins in gram negative bacteria using Gel Clot technique • Prepared reports• Environmental management including water, sanitation and hygiene monitoring• Regular maintenance, calibration and troubleshooting of autoclave, pH meter, incubators, microscope and the biosafety cabinet • Took part in all stability new product stability programmes and create R&D specifications for raw materials and finished products Show less

Harare, Zimbabwe

• Received raw materials for production processes and carried out microbiological testing to ensure raw materials met the company’s high standards • Rejected and documented all products and materials that failed to meet specifications, directing such items to initial production or repair as appropriate• Handled customer complaints• Received raw materials for production processes and carried out microbiological testing to ensure raw materials met the company’s high standards… Show more • Received raw materials for production processes and carried out microbiological testing to ensure raw materials met the company’s high standards • Rejected and documented all products and materials that failed to meet specifications, directing such items to initial production or repair as appropriate• Handled customer complaints• Received raw materials for production processes and carried out microbiological testing to ensure raw materials met the company’s high standards • Monitoring the fermentation process • Purified water analysis • Performed quality checks on production lines• Rejected and documented all products and materials that failed to meet specifications, directing such items to initial production or repair as appropriate• Laboratory housekeeping as well as equipment calibration• Handled customer complaints• Performed test runs on raw materials and potential new products• Step-by-step quality checks and audits in production during day or night shifts• Safety and Environmental management of the plant during production• Water analysis before production• Ensured the finished product was safe and met the company’s standards and specifications• Auditing manufacturing lines• Conducted audits after an item was on the market for some time to determine where future products could be improved. • Edited audit blueprints and Quality Control policies to improve effectiveness • Compared company products with competitors’ products and together with Procurement Department, wrote technical reports citing areas to be enhanced. • Served as a liaison between the professionals on the production floor and the company’s salespersons Show less

Hsc Equivalent

Honours Degree, Biochemistry

Activities and Societies: Biochemistry United Students Association deputy chairman (Pioneer)