Dorota Urbańska

Microbiology and Sterilization Coordinator at LiNA Medical
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Contact Information
us****@****om
(386) 825-5501
Location
Poznan Metropolitan Area, PL
Languages
  • English -
Skills

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Credentials

  • Sterilization Process Manager
    TUV Nord
    Nov, 2019
    - Nov, 2024
  • Auditor wewnętrzny systemu zarządzania jakością urządzeń medycznych ISO 13485:2016
    BSI

Experience

  • LiNA Medical
    • Denmark
    • Medical Equipment Manufacturing
    • 100 - 200 Employee
    • Microbiology and Sterilization Coordinator
      • Jan 2018 - Present

      • Coordination of all validation/revalidation sterilization activities according to internal procedures and Ethylene oxide and Radiation sterilization standards.• Overall responsibility for the sterilization processes (Ethylene oxide and Radiation sterilization) applicable to the product / analytical equipment including: validation/revalidation, new products implementation to validated cycles.• Performing of supplier audits of sterilization service providers.• Supplier qualification related with sterilization and product sterility.• Management of Laboratory (all laboratory processes supervision + substantial supervision of the laboratory employees).• Creation and update of the quality documentation acc. to the quality standards implemented within the company • CAPA process//NC process follow.• Overall responsibility for microbiological analysis of product, raw materials and environment: sampling plan creations, sampling, analysis, reporting, chemicals management.• Overall responsibility for laboratory including equipment’s qualification, logbooks, laboratory cleaning and disinfection, aso.• Statistic process analysis. Show less

    • Microbiology Specialist
      • Jul 2016 - Dec 2017

      • Management of Laboratory (all laboratory processes supervision + substantial supervision of the analyst)• Supervision of validation/revalidation of irradiation sterilization• Creation and update of the quality documentation acc. to the quality standards implemented within the company • Overall responsibility for microbiological analysis of product, raw materials and environment: sampling plan creations, sampling, analysis, reporting, chemicals management.• Overall responsibility for laboratory including equipment’s qualification, logbooks, laboratory cleaning and disinfection, aso.• Validation of analytical methods used in the laboratory.• Follow the CAPA process/OOS procedure/NC procedure.• Statistic process analysis. Show less

    • Analyst
      • Oct 2013 - Jun 2016

      • Overall responsibility for microbiological analysis of product, raw materials and environment: sampling plan creations, sampling, analysis, reporting, chemicals management.• Overall responsibility for laboratory including equipment’s qualification, logbooks, laboratory cleaning and disinfection, aso.• Validation of analytical methods used in the laboratory.• Follow the OOS procedure/NC procedure.• Taking the corrective/preventive actions needed to eliminate potential/observed contamination; CAPA process.• Statistic process analysis. Show less

Education

  • Nicolaus Copernicus University Ludwik Rydygier Collegium Medicum in Bydgoszcz
    Master's degree, Biotechnology
    2008 - 2013

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