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Regulatory Affairs, Quality Manager, Production Manager
NAME ADDRESS TELEPHONE EMAIL NATIONALITY PASS PORT NO. RACE : : : : : : : DR. GEORGE MUGI M. P. O. BOX , PARKLANDSNAIROBI. Mobile + or + KENYAN A BLACK
Work experience HeadQuality Assurance/Authorized Person in Universal Corporation Ltd WHO prequalified Company since for production of Lamivudine/ Zido vudine tablets
Dec to date Key duties x Ensu res compliance of GMP by developing, implementing and maintaining pharmaceutical quality systems. x Ensures compliance with the regulatory requirements as set out in the Pharmacy and Poisons Board Act cap involved in maintaining purity, safety and efficacy of drugs. x Supervises the development of the trial batches of new products as per the market requirements, approves formulations, and suggests product and process improvement. x Participates in the development of the Quality Manual, Site Master File, Protocols, SOPs, Batch manufacturing records and other quality documents. x Ensures that the process validation, cleaning validation, analytical method validation, qualification, stability studies is performed in time. Reviews/approves the documentation required for these projects. x Supervises and participates in internal audits, materials and co ntract laboratories audits and approval. x Reviews and authorizes deviations and change controls. x Manages incidents such as complaints and product recalls. x Reviews batch manufacturing records and approve/disapprove the release of finished products for sale. x Implements the necessary modification to existing occupational
health and safety programs to achieve a program consistent with OHSAS . x Coo rdinates the establishment, implementation, maintenance and improvement of the Environmental Management System in conformance to ISO . x Assists WHO PQ Project Coordinator in developing the product, preparation of dossier. x Assists in preparation and/or review of dossiers for submission to drug regulatory authorities.
Director since in Kikuyu Water Company water service provider to o ver a population of over and Chairman of the Audit Committee. Chairman of Industrial Pharmacy Subcommittee of Pharmaceutical Society o f Kenya.
Production Manager PZ Cussons East Africa Ltd Company
Pharmacist in the Cosmetics, Medicaments and Household factory. Key duties: x Ensured that all company pharmaceutical products are fully registered with regulatory authorities by compiling the registration documents, submitting to the authorities, following up and interacting as necessary with them to effect approval of registration applications for products intended for both the local and the international markets. x Ascerta ined that all the Laws governing manufacture and sale of Pharmaceutical ,Cosmetics and Household products are correctly interp reted and complied with, by ensuring that all the products are pro cessed , packaged and stored following Good Manufacturing Practices, Company Standard Operating Procedures, identifying possible issues of non compliance , interacting with regulatory bodies, ad vising on the necessary action to ensure compliance. x Supervised production of all designated products on a day to day with a view to meeting production targets, by anticipating and resolving problems that may hamper normal rates of production, cocoordinating daily and activities and effected changes as necessary in order to utilize full y the resources available in the designated manufacturing areas so as to optimize output, frequently inspecting dispensing and batch processing activities as well as personally patrolling all manufacturing lines with a view to identifying possible irregularities in established pro cedures and propose improvements, closely cooperating with produ ction supervisors to achieve unhampered flow of raw and packing material to the lines, intermediate and final products between processing
area, finishing lines and into the store, deciding on optimum layout of the factory equipment and work forces so as to make best use of available working space. x Ensured proper Raw and Packaging Materials management by estab lishing the required quantities and requesting the same from the Store, protecting the same from spoilage while in work in progress, monitoring the rate of consumption, organizing stocktaking weekly or after each production run, reconciling possible differences between theo retical and actual usage and returning excess materials to the stores.
x Accountab le for safe custody of sensitive materials eg ensuring that Ind ustrial Methylated Spirit is procured, stored used and the necessary do cu mentation is done, in conformity to Customs and Excise Act requirement by to ascertaining overall compliance at company level with statutory requirements, holding responsibility for the safe segregated storage, handling and dispensing material. x Liaising with the Engineering Dept. in order to maintain the designated manufacturing premises and equipment in good operating condition by identifying problems and offer ideas for improvement of plant efficiencies, monitoring adherence to the agreed preventive maintenance, cleaning and lubricating procedures and following up personall y the progress of repairs of faulty production equipment with a view to minimize idle time of plant due to breakdowns and increase utilization. x Efficiently communicating information to the Company Management and liaising as appropriate with other Departments on any issue or problem that may affect the production department smooth operation by particip ating in the Weekly Production Meeting , to availing as needed expertise in the fields of Pharmacy and related disciplines, to maintaining and updating documents, files and records both in hard cop y and computerized forms regarding specifications, profiles, batch manufacturing records, line loads and personnel allocation, issuing and circulating as necessary weekly and monthly production planning and summary reports, monitoring the correct flow of documentation. x Ensu ring proper personnel management by coordinating activities of staff and casual personnel, delegating tasks and responsibilities, co ntrolling performance and assessing outcome of the efforts, pro vid ing assistance and motivation, managing interpersonal conflicts, co mmenting on attitudes, taking disciplinary action as necessary, endeavo ring to create an agreeable and productive working environment and generally caring for the welfare of the subordinates.
Ensuring both staff and casual workers are properly trained to meet job demands by personally guiding operators on how to improve their efficiency and promoting among workforce the importance of achieving the best possible product quality and flawless presentation x Ensuring that health and safety regulation s are fully observed and anticipating and resolving and potentially hazardous situation by personally training newcomers in observing safety precautions, training on safe handling of powders and of flammable materials, exercising alertness as to possible security risks in and around the products manufacturing Buildings and Flammable Stores.
Ja n. April
Qualit y Control Pharmacist Laborato ry and Allied Ltd Nairobi
July Dec July July
Hospital Pharmacist Wesu District Hospital, WUNDANYI Pharmacist Intern Coast General Hospital
Educationa l Background
University of Nairobi Attained B. Pharmacy Degree Examination for the Kenya Advanced Certificate of Education Njiris High Scho ol General paper Subsidiary Pass, Maths Alternative s Principal pass, Chemistry Principal pass, Biology Principal pass Examination of Kenya Certificate of Education Kirimara Sec. School English language , Literature , history , Geography , Mathematics Alt.S , Agriculture , Biology , Physical science Aggregate Certificate of Primary Education Ngaini Grad es attained; English A, Mathematics B+ and General subjects A
Forensic Pharmacy examination from University of Nairobi Registratio n to practice as a pharmacist from the MOH Pharmacy and Poisons Board Kenya.
Kilimanjaro School of PharmacyTanzania and Department of Industrial and Physical Pharmacy, Purdue University USA: Qualification attained:
Post Graduate Diploma Course in Industrial Pharmacy Advanced Training in Drug Discovery , Drug Development, Regulatory &Quality Compliance, Drug Manufacturing Process & manufacturing Lab, Regulatory documents & Generic approval Submissions
thth May Worksho p on selected GMP topics with relevance for pharmaceutical manufacturers and GMP inspectors in Kenya.
Coo rganized by: World Health Organization Prequalification of Medicines
Pro gramme , Deutsche Gesellschaft für Internationale Zusammenarbeit GIZ Gmb H and Action Medeor e.V., GMP inspectorate of Pharmacy and Poison Board in Kenya PPB. thth April th th June UN Prequalification of Medicines, Diagnostics and VaccinesPQ, Dossier and GMP workshop, CICG, Rue de Varembe, Geneva, Switzerland. Occupational Health and Safety management Systems auditor/Lead Auditor Training Course No. A certified by the International Registrar of Certified Auditors IRCA. This course satisfies the training requirements for the IRCA OH&S Auditor Certification Scheme BV, Nairobi, Kenya Enviro nmental Management Systems auditor/Lead Auditor Training Course certified by the International Registrar of Certified Auditors IRCA. This course satisfies the training requirements for the IRCA EMS Auditor Certification Scheme SGS, Kenya WHO Training workshop for pharmaceutical Manu facturers and regulatory assessors of medicines held in Kampala Uganda.
Cleaning validation and Process Validation by BEGECA. WHO Training Workshop on Development of Pharmaceutical Products, Cape Town, South Africa
th th Sept.
rd th Feb
ndth Ma y th t h Apri l
Word; Excel; Power Point,
Kiswa hili Speaking competence: School level Engl ish Speaking competence: Fluent Written competence: School level
Written competence: Good.
Driving license, Fire Warden
. Name: Title: Dr Kay Weyer Project ManagerWHO Prequalification
Company: Universal Corporation Ltd Pho ne: Email: . Name: Title: + Prof. Stephen R. Byrn Charles B Jordan Professor of Medicinal Chemistry Department Head
Institution: Purdue University Phone: Email: . Name: Title: ue .edu Dr W.O. Wanyanga Execu tive Director
Company: PharmaQ Limited Pho ne: Email:
+ ; + ;
Date: th March