Highlights:

Skills:Analytical skills, Data Integrity and GDP and cGMP, Quility Assurance, Quality control, Management, Communication, Laboratory Testing

Quality Control Coordinator/Microbiologist 01/01/2020 - current
Specpharm Holdings, Johannesburg, Gauteng South Africa
Industry: Pharmaceutical
Reliable and highly accurate Biotechnologist professional able to apply technical expertise to routine testing, evaluation of data, problem-solving of trends, compliance with applicable procedures and regulation, and support of continuous improvement efforts
• Work with Quality Control • Department, laboratory director, and manager to plan, qualify, verify, and validate tests/assays and equipment. • Create and review standard operating procedures to adhere to regulatory standards • Evaluate QC Laboratory practices and processes for improvement opportunities and ensuring regulatory requirements are met. • Liaison between the quality control department and other departments, clients and suppliers on raw material, stability samples, and finished product. • Preparation stability protocols, coordinate sampling, testing and generation of summary reports. • Create, manage and update specifications of products, active pharmaceutical ingredients, raw materials, reference standards and approvals. • Perform microbiological tests on water, raw materials, finished products and packaging materials according best practice requirements. • Identify the presence of possible pathogenic organisms, whenever growth is observed. • Perform Preservative Challenge testing, sterility testing and growth promotion testing. • Performed Chemical, microbial, Gas Chromatography analysis, Titrations, using AA, UV/Vis, IR and FTIR and High Performance Liquid Chromatography using Waters and Shimadzu. • Review records, test results and data for completeness, accuracy, and compliance with specifications and requirements; track and monitor assigned projects. • Perform evaluation of internal controls, communications, risk assessments, and maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory standards. • Initiate and follow-up on all change controls, deviations and all departmental CAPA’s • Assist in investigations, root-cause analysis and commitments to associated CAPA’s related to deviations and out of specification results. • Ensure the maintenance and internal verification of laboratory equipment is performed. • Manage calibration by external service providers for all equipment and associated systems. • Maintaining Standard Operating Procedures and training records for the Quality Control department. • Participate in internal, external audits, draft and follow up on audit findings responses. • Implement training programs; train laboratory personnel on requirements, processes, and procedures.--
Biotechnologist 10/02/2018 - 12/27/2020
National Institute of Communicable Diseases, Johannesburg, Gauteng South Africa
Industry: Diagnostic Laboratory
Performing microbiological tests on water, raw materials, finished products and packaging materials as well as sterility testing. Performing all microbiological tests and procedures in a precise, accurate and efficient manner using Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP). Reviewing Standard Operating Procedures (SOP’s).
• Perform microbiological screening, identification and characterization, and molecular biology test procedures. • Communicate with submitters according to procedures regarding specimen collection, packaging, shipping to the laboratory. • Maintain laboratory equipment and report equipment problems according to procedures. • Comply with agency policy regarding safety, security, and protection in the working environment in accordance with the laboratory’s procedures and policies. • Perform all laboratory work (e.g., testing procedures, safety protocols, quality control protocols) according to written standard operating procedures. • Report results accurately and completely within the laboratory information management system(s). • Operate laboratory instruments in accordance with SOPs. • Maintains records for all testing performed. • Apply concepts and relevant theories to interoperate tests that are being performed. • Assist with maintenance of inventory of laboratory supplies and equipment by determining when such supplies, equipment and chemicals must be ordered. • Perform testing and prepare results for subsequent secondary review and release following verification and processes associated with building renovation. • Store relevant isolates on semi-solid media as well as micro bank • Environmental monitoring (Hospital /clinical) samples for study relevant pathogens • Perform food quality test on food, water and milk samples including but not limited to: E. coli, Coliforms, TotalPlate Counts, Salmonella, L. Monocytogenes, Bacillus Spp, S. aureus and Yeast and Mold. • Identification of Listeriosis species found in specimens collected from foods and the environment- Listeriosis Outbreak in South Africa. • Micro-organism isolation, maintenance and characterization of relevant pathogens of interest • Perform manual and automated microbial susceptibility test on isolated pathogens of interest • Collect and maintain a library of organisms necessary for molecular testing; records data and store relevant isolates on semi-solid media as well as micro bank--

Cape Peninsula University of Technology 01/01/2008 - 12/30/2013
Cape Town , Western Province, United States
Degree: Bachelor's Degree
Major:Microbiology ,Molecular Biology. BiochemistryAnalytical and Inorganic Chemistry
Minor:Bio-processing Immunology
Completed and passed.