Olalekan Awoyinfa

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Olalekan Awoyinfa

Locality: Oxford, United Kingdom
Summary: With a background in Chemistry and certification as Public Analyst I specialize in businesses involved in manufacturing pharmaceuticals, medical devices or devices for the packaging and dispensing of pharmaceuticals, foods and non-foods products and pharmaceutical research. My approach is to provide a business with adaptable and responsive quality management system that adds value to the business, reduces cost and waste and provides a competitive edge against competitors. A Quality Assurance professional with wide range of experience in Quality Control, Quality Assurance and Regulatory Compliance. Very good knowledge and experience of current Good Manufacturing Practice (cGMP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP), ISO 13485, ISO 9001, FDA 21CFR Part 820, 21 CFR Part 11 & 21 CFR Part 58 Quality Management Systems Quality Management skills and experience in both basic and fast paced automated pharmaceutical/medical devices manufacturing, drugs discovery & development research Knowledge and experience in conducting, leading and managing QA audits of GxP systems, processes & procedures and extensive knowledge of GMP, GLP, ICH/GCP requirements and the drug development process; including the ability to review and evaluate data, records and reports to assure compliance with own and/or Sponsor SOPs, contractual obligations, relevant GxP regulations and ISO requirements. Excellent attention to details, strong numerical skills with highly developed problem solving skills and the ability to be able to resolve difficult situations. Able to use own initiative and work as part of a team under pressure to meet challenging deadlines/ objectives. Working knowledge of the application of computerized systems (ERPs such as SAP, ORION, Documentum, Trackwise, off the shelf/bespoke applications etc) to quality management
Past: QA Auditor at Bespak Plc QA Manager/Management Representative at Afrab-Chem Limited
Education:  University of Ibadan Analytical Chemistry (1987-1988) Graduated in modules including Food Analysis, Soil Analysis Analytical Techniques(Instrumental & Classical 'Wet' chemistry), Statistics, Environmental chemistry, Research Methodology and Project/Dissertaion on 'The use of sulphate-sulphur as indicators of sulphur dioxide pollution'
 University of Ibadan C...
Industry: Research
Skills: Quality Sytem Management(GLP, GMP, GCP, ISO 9001, ISO13485, ISO17025 and ISO 14001) Leading and Conducting QA audits
Experience: ICON Development Solutions (formerly Veeda Clinical Research) (Research industry): QA Auditor,  (2007-Present) 
Bespak Plc (Medical Devices industry): QA Auditor,  (September 2007-June 2008) 
Afrab-Chem Limited (Pharmaceuticals industry): QA Manager/Management Representative,  (July 1991-August 2006) Various QC, Operation & ...
Interests: career opportunities, consulting offers, new ventures, job inquiries, expertise requests, business deals, reference requests, getting back in touch

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