Robert Nsimba
Senior Quality Specialist @Thermo Fisher Scientific
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WORK HISTORY
Senior Quality Specialist @Thermo Fisher Scientific
Greenville, NC, US
Perform daily quality assessments of facility, personnel, and documentation both classified and non-classified areas to uncover errors or deficiencies, assure quality, and compliance per site procedures and cGMPs. • Daily interaction with employees to assist with troubleshooting, documentation corrections/notes, and guidance with aseptic technique• Champions quality culture by aiding personnel in understanding application of policies and controls• Participates in RAPID event response and provides quality guidance for deviation events• Advances deviation events to the appropriate area and quality management• Performs quality review and approval of procedures, training documents, and forms of moderate to high complexity• Performs quality review and approval of deviation and change control of moderate to high complexity• Participates as the quality assurance representative in Root Cause Analysis to support deviation investigations of moderate to high complexity• Performs quality batch record review• Aids in identification of continuous improvement opportunities; Participates in practicalprocess improvement initiatives
EDUCATION
Osaka Prefecture University
M.Sc., Food Chemistry
University of Kinshasa
Bachelor, Chemistry & Agro-Industries
Osaka City University
Ph.D., Bio-functional Chemistry
ABOUT ROBERT NSIMBA
Quality professional with 12+ years of experience in QC and QA within the pharmaceutical industry. Expertise in GMP documentation (authoring, reviewing, and approving), root cause analysis, CAPA implementation, and supporting regulatory inspections and audits. Passionate about strengthening quality culture and training teams in aseptic best practices. Proven track record of driving continuous improvement, enhancing compliance, and supporting operational excellence. I am motivated to bring my expertise to a forward-thinking organization committed to quality and patient safety.
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