Kholofelo Mphahlele

KHOLOFELO MOKGANYETSI MPHAHLELE CHEMISTRY AND BIOCHEMISTRY GRADUATE DETAILS East-on- 82 Apartments, Kibler Park, Johannesburg, 2091, South Africa-- Nationality South African Driving license Code B LINKS www.linkedin.com/in/KM-Mphahlele LANGUAGES Setswana Sepedi English CORE COMPETENCIES Strong verbal and written communication skills Honesty and transparency Excellent Numerical skills Time management skills Chemical quality assurance Orderliness and detail focused Good manufacturing practice Ability to comply with all applications standard required by the company Adhere of SAHPRA Dynamic and highly motivated Chemist with a BSc Degree in Chemistry and Biochemistry. Offering a strong background in Chemical Analysis, Quality Control, and Research and Development, combined with expertise in analytical instrumentation, method performance and healthy and safety standard. Highly adaptable to challenging environments with an eagerness to advance professional in laboratory position. Meticulously documents observations in a concise and timely manner with a focus on accuracy and maintaining a sterile and organized work environment. EDUCATION BSc Degree in Chemistry and Biochemistry, University of South Africa, Pretoria July 2014 BTech in Pharmaceutical Sciences, Tshwane University of Technology, Pretoria In Progress Grade 12, Ngwana Mohube High, Limpopo December 2003 EMPLOYMENT HISTORY Regulatory Affairs Chemist at Fine Chemicals Coorporations (Aspen) November 2015 — December 2016 ● ● ● ● Ability to accurately track inventory and compile reports Resilience Document control and management ensuring that QC specifications are compiled and amended as required by QA/QC. Updating CTD’s, manufacturing documents, annual reports and deficiency responses for regulatory authorities submission. Preparation of dossiers for submission to MCC, FDA, SAHPRA etc. And investigated customer complaint (non-conformance) Created and Maintained package inserts and Information leaflets. Established and kept obligations with the key external markets like IPASA, MRA/SAHPRA and FDA, as per pharmacy act 53 of 1972. Reseach Scientist at CSIR July 2015 — October 2015 ● ● ● ● Performed quality control on instrumentation and equipment to comply with established specifications and protocols Sample receiving, sorted and checked samples according to the request forms Performed wet chemical and instrumental analysis of raw material, batches and finished goods for basic nature of polymers and its composite. Reported deviations and reported non-conformance on product testing and take corrective measures. ● Documented information by maintaining daily logs and equipment record books ● Prepared and assured accuracy of standards and reagents needed for analysis. ● Adhere to safety and clean area procedures to comply with agency and regulatory mandates Laboratory Analyst at Triton Pharmacare March 2014 — March 2016 ● Highly motivated, energetic, sound judgement and good reasoning skills Stability testing - PROFILE Chromatography Ability to handle multiple competing priorities and utilize resources effectively KIBLER PARK, JOHANNESBURG, 2091, SOUTH AFRICA ● ● Performed rigorous testing of raw materials, water, semi-finished and finished medical goods with HPLC, GC, AA, pH Meter, Polarimeter, viscometer, dissolution bath, melting point, karl fischer, UV spectrophotometer, IR, refractive index and Auto titrator ensuring adherence to regulatory standards and internal procedures. Documented all test result accurately in lab ensuring traceability and compliance with GMP requirements. Implemented ISO 9001 SOP’s. Collaborated with R&D/Technical Services on new product testing and introduced improvements to lab procedures. Successfully participated in investigation to determine root cause of out-of-specification results. Good understanding of applicable laws, standards, and specifications Knowledge of quality control operation Possess good innovation and initiative skills in laboratory practices environment for ease in taking ownership and accountability REFERENCES Ms Marvin Masemola, RA Supervisor from Fine Chemicals -·- Dr Mukhotu, Laboratory Manager from CSIR - Mrs Flora Mabathe, Laboratory Supervisor from Trito Pharmacare -·-