Michael Waweru Email & Phone Number

Kenya

Kikuyu, Kiambu, Kenya

1) Undertook the installation and qualification of over 50 new/modified manufacturing and analytical equipment, achieving 100% capitalization of assets within projected timeframes.2) Prepared and executed 100+ re-qualification protocols for various equipment and utility systems including HVACs, purified water and compressed air systems, resulting in 60% reduced down-time caused by user errors.3) Performed computerized system validation (CSV) tests for 6 installed systems used within the… Show more 1) Undertook the installation and qualification of over 50 new/modified manufacturing and analytical equipment, achieving 100% capitalization of assets within projected timeframes.2) Prepared and executed 100+ re-qualification protocols for various equipment and utility systems including HVACs, purified water and compressed air systems, resulting in 60% reduced down-time caused by user errors.3) Performed computerized system validation (CSV) tests for 6 installed systems used within the facility i.e. Trackwise, SAP, LIMS, Valgenesis, Chromeleon and Compliancewire, ensuring 100% compliance to 21CFR part 11 requirements.4) Assessed effectiveness of user training and SOPs for all newly qualified equipment and systems prior to commissioning, reducing deviations resulting from incorrect operation by 50%. 5) Orchestrated spot audits for QC and Engineering departments resulting in a cumulative 10% reduction of poor documentation practices and procedure deviations.6) Collaborated on WHO and customer audits as subject matter expert (SME) for equipment and utilities, with an outcome of 80% less observations made over 5 consecutive audits, and 70% of the observations being classified as minor.7) Completed 20 CAPAs in response to regulatory and internal audit findings, resulting in 0 repeat observations during subsequent audits.8) Facilitated calibration for 500+ instruments and equipment annually by external service providers (ESPs) or internal engineering team, which led to 0% in deviations to calibration timeframes.9)Managed execution of facility qualification and temperature mapping studies for 15 storage areas and equipment within the facility, with 90% reduction in temperature excursions observed within the facility.10) Joined in 20 cross-functional team meetings and project plan development for major facility modifications and equipment integration, achieving 60% increase in the project implementation rate.11) Drafted 50 quality risk assessments using FMEA tool Show less

Kikuyu, Kiambu, Kenya

1) Evaluated raw materials, intermediate and finished products for an assortment of over 30 registered pharmaceutical products as per current good manufacturing practices.2) Executed 5 acceptable quality level tests in response to market complaints /notifications as part of quality management systems.3) Maintained updated calibrations of 50+ analytical instruments used for in-process checks within the facility.4) Performed 50+ analytical analysis of water samples as part of the… Show more 1) Evaluated raw materials, intermediate and finished products for an assortment of over 30 registered pharmaceutical products as per current good manufacturing practices.2) Executed 5 acceptable quality level tests in response to market complaints /notifications as part of quality management systems.3) Maintained updated calibrations of 50+ analytical instruments used for in-process checks within the facility.4) Performed 50+ analytical analysis of water samples as part of the cleaning validation process.5) Participated in batch manufacturing record review for 30+ different products as part of the product release procedure. Show less

Karen, Kenya

1) Collaborated on 2 research projects in bacteriology and parasitology.2) Aided in calibration and operation of 5 storage and analytical equipment.

Bachelor’S Degree, Medical Biotechnology, Second Class Honours - Upper Division

Certificate, Basic Computer Applications, A-