About

Detail-oriented Quality professional with a background in Analytical Chemistry and hands-on experience in EO sterilization, process validation, sterility assurance, and regulatory audits. Proficient in ISO 11135 (EO sterilization) and ISO 13485 (medical devices), certified as Internal Auditor for ISO 45001 and ISO 14001. Experienced in QHSE programs, CAPA implementation, and audit compliance (Internal, Customer, Supplier, KEBS, PPB, ITS, SGS, and NEMA). Strong foundation in analytical method validation (ELISA, integrating GC-based EO& ECH residual analysis into sterilization process validation), CI verification and BI culturing. Adept at integrating laboratory expertise with quality and safety systems knowledge to drive compliance, sterility assurance, and product safety while fostering continuous improvement.

Skills

  • Communication
    10
  • Teamwork
    10
  • Problem-Solving
    10
  • Creativity
    10
  • Leadership
    10
  • Quality control and quality assurance
    10
  • Quality Standards & Audits: ISO 9001/11135/13485
    9
  • English
    10
  • Swahili
    10

Recommendations

Experience

Sitati Sitati

1/2/2024
9

"He's services are excellent."

Jared Odhiambo

7/31/2023
7

"Hardworking "