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

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Sitati Sitati

1/2/2024
9

"He's services are excellent."

Jared Odhiambo

7/31/2023
7

"Hardworking "

Experience

ooko vincent

Work experience
  • Sterilization Technician / Engineer
  • Quality Department: Sterility Assurance, EO Validation & Compliance
  • Fullcare Medical Kenya SEZ & Fullcare Medical Kenya EPZ Subsidiaries of Zhende Medical, China
  • HQ
  • Aug 2024 – Present
  • Oversee EO sterilization cycles following SOPs and safety procedures to maintain
  • process control and product sterility.
  • Coordinate EO/ECH residual verification (ISO 10993-7), BI-based sterility assurance (ISO
  • 11138), and CI-based process verification (ISO 11140), supporting sterilization process
  • validation.
  • Execute annual EO sterilization validations (IQ/OQ/PQ), successfully validating 5 cycles
  • for Phase I and Phase II projects.
  • Conduct CAPA investigations, including root cause analysis, implementing corrective
  • action, and closure of over 20 non-conformities, within target timelines.
  • Prepare documentation and participate in internal, customer, KEBS, PPB, and ITS audits,
  • achieving zero major non-conformities in recent inspections.
  • Deliver QHSE and compliance training to 15 staff, enhancing documentation practices
  • and adherence to SOPs.
  • Collaborate with QA, Regulatory, PMC, Engineering, and Production to optimize
  • sterilization processes and compliance.

ooko vincent

Work experience
  • September, 2021 - December, 2021
  • Fulltime
  • Soft and hard record keeping Navision ERP system
  • Source documents and control Collecting samples from trucks for lab analysis
  • Grading samples as per the KEBS standards
  • Determination of aflatoxin levels using HELICA kit

ooko vincent

Education
  • August, 2018 - December, 2022
  • Fulltime
  • Collection of samples
  • Preparation of samples for analysis
  • doing the analysis
  • preparing laboratory reports
  • Maintaining laboratory apparatus

Sitati Sitati

1/2/2024
9

"He's services are excellent."

Jared Odhiambo

7/31/2023
7

"Hardworking "