Augusta Njongwe

Augusta Njongwe

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Quality Assurance | Equipment Qualification (IQ/OQ/PQ) | CQV | Project & Validation Lifecycle Management
County Limerick, Ireland

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Résumé


Jobs verified_user 0% verified
  • Regeneron
    QA Validation Consultant
    Regeneron
    Nov 2024 - Current (1 year 11 months)
    • Lead the qualification of manufacturing equipment.
    • Author, review, and approval of validation documentation in compliance with data integrity standards.
    • Coordinate and support the execution of validation tests. Contracted via Innopharma Technical Services
  • Innopharma Technical Services
    Validation Engineer
    Innopharma Technical Services
    Jan 2024 - Current (2 years 9 months)
    • Validation Protocol Development (IQ, OQ, PQ)
    • Equipment Qualification
    • Cleaning Validation
    • Process Validation
  • Boston Scientific
    Validation Engineer
    Boston Scientific
    Jun 2024 - Nov 2024 (6 months)
    • Lead the qualification of equipment across production lines to optimise manufacturing efficiency.
    • Supported software updates on equipment, working closely with IT to ensure smooth integration and compliance.
    • Conducted Installation and Operational Verification Testing (IVOT) in line with regulatory standards (ISO 13485, FDA).
  • MSD Ireland
    Manufacturing Intern
    MSD Ireland
    Jun 2023 - Nov 2023 (6 months)
    • Hands-on experience in GMP cleanroom environments.
    • Experienced with automated systems including MES, DeltaV, and SAP.
    • Facilitated Grade C/D Gowning training sessions for new staff onsite.
    • Authored technical documentation.
    • Supported buffer and media preparation.
Education verified_user 0% verified
  • Dublin City University
    Dublin City University — Bachelor of Science, Chemical and Pharmaceutical Sciences
    Dublin City University
    Jan 2019 - Dec 2023 (5 years)
  • Dublin City University
    bachelor, Bachelor of Science, Chemical and Pharmaceutical Sciences
    Dublin City University
    Jan 2019 - Jan 2023 (4 years 1 month)
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