Loise Nauwagos

An articulate, energetic, and highly dedicated Quality Assurance and Quality Control professional with over six years of progressive corporate experience across the pharmaceutical and medical device manufacturing industries in Kenya. Adept at establishing regulatory frameworks, implementing rigorous cGMP and ISO quality systems, managing documentation workflows, and driving continuous improvement. Demonstrates excellent analytical capacity, a proactive work ethic, and exceptional leadership skills in training operational teams to deliver high-quality standards under minimal supervision.

Quality Assurance Executive at Revital Healthcare (EPZ) Ltd (2024-02 – 2026-05)

• Enforced strict organizational compliance with ISO 9001 and 13485:2016 and statutory current Good Manufacturing Practices (cGMP).
• Analyzed comprehensive quality assurance data sets, preparing evaluation reports and performance recommendations for executive management.
• Formulated and directed training modules for line operators and assistants to anchor decentralized quality control frameworks on the production floor.
• Inspected engineering assemblies, calibrated highly specialized production instrumentation, and validated operational states to ensure optimal process control.
• Managed multi-stage sampling routines for incoming, intermediate, and finished medical products against established quality metrics and initiated localized containment strategies when variances occurred.
• Spearheaded systematic Risk Assessment and Evaluation procedures to pre-emptively mitigate regulatory and production vulnerabilities.
• Authored, customized, and systematically reviewed critical quality documentation including Standard Operating Procedures (SOPs), Batch Manufacturing Records (BMRs), Batch Packaging Records (BPRs), and operational worksheets.
• Supervised structural qualification projects for manufacturing machinery and analytical laboratory suites.
• Conducted full paper-based batch history audits to verify regulatory traceability, clarity, and unconditional compliance before batch release.
• Successfully led and executed the design, implementation, and standard cGMP documentation workflow for a brand-new, multi-million shilling Rapid Diagnostic Test (RDT) production facility.
• Spearheaded standard CAPA identification and implementation workflows resulting in zero non-conformances during stringent international oversight audits conducted by the World Health Organization (WHO) and TÜV Rheinland.
• Achieved full implementation of occupational hygiene standards via comprehensive OSHA training integration for factory floor teams.

Quality Assurance Officer at Nerix Pharma Limited (2021-02 – 2023-12)

• Managed overarching validation lifecycle tracks spanning precise Process Validation protocols and complex Equipment Qualifications (IQ/OQ/PQ).
• Maintained enterprise-wide corporate compliance standards across commercial formulation lines to achieve structured technical benchmarks.
• Investigated external market complaints, conducted root-cause analyses, and implemented robust preventive controls.
• Audited finished goods batches against step-by-step regulatory batch requirements to guarantee safe marketplace delivery.
• Formulated corporate CAPA matrices addressing internal deviations, external agency oversight, and independent self-inspections.
• Compiled raw production metrics into localized Excel tracking engines; calculated key performance vectors for standard Annual Product Quality Reviews (APQR).
• Successfully coordinated facility-wide readiness and documentation frameworks that passed rigorous regional inspections by the Tanzania Medicines and Medical Devices Authority (TMDA/TFDA).
• Seamlessly integrated structural qualification certifications for newly procured automated production hardware, keeping rollout schedules within cost and time parameters.

Microbiologist (Quality Control Department) at Nerix Pharma Limited (2020-01 – 2021-01)

• Conducted exhaustive microbial testing frameworks on raw pharmaceutical inputs, intermediate compositions, packaging systems, and finished commercial lots.
• Executed physical, chemical, and microbial assay assessments on industrial purified water loops and reverse-osmosis storage networks.
• Maintained continuous environmental monitoring programs inside sterile manufacturing chambers via standard plate-exposure and active air-sampling techniques.
• Calibrated critical laboratory hardware including modern autoclaves, analytical balances, pH meters, and microbial incubators.
• Isolated and identified regional microbial strains utilizing Gram-staining, differential media typing, and biochemical profiling.
• Managed stock culture preservation lines, executing regular sub-culturing, viability tracking, and standard cryopreservation protocols.

Research Assistant (Malaria & Schistosomiasis Laboratory) at Kenya Medical Research Institute (KEMRI) (2018-06 – 2018-08)

• Deployed demographic and epidemiological questionnaires to handle structured data collection in the field.
• Processed biological clinical samples and prepared standardized micro-reagents and active controls.
• Drafted foundational lab-specific Standard Operating Procedures (SOPs) to advance internal accreditation initiatives.
• Executed complex molecular and serological techniques, including Enzyme-Linked Immunosorbent Assays (ELISA), Gel Electrophoresis, and viral/bacterial RNA detection protocols.

Post-Graduate Diploma in Education (PGDE) in Education – KCA University, Kenya (2024)

Bachelor of Science in Medical Biotechnology with IT – Maseno University, Kenya (2015 – 2019)

Kenya Certificate of Secondary Education (KCSE) – Kapsabet Girls High School, Kenya (2011 – 2014)