Ewa Rybak

QMS Manager/Qualified Person at Polpharma Biologics
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Contact Information
us****@****om
(386) 825-5501
Location
Gdańsk, Pomorskie, Poland, PL
Languages
  • English -
  • Polish -

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Experience

  • Polpharma Biologics
    • Poland
    • Biotechnology Research
    • 700 & Above Employee
    • QMS Manager/Qualified Person
      • Feb 2021 - Present

    • Quality Compliance Expert/Qualified Person
      • Jan 2020 - Feb 2021

  • Warsaw University of Technology
    • Poland
    • Higher Education
    • 700 & Above Employee
    • Academic Lecturer
      • Feb 2019 - Present

      Quality Management Quality Management

  • Novartis
    • Switzerland
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Qualified Person
      • Jan 2019 - Dec 2019

      • Certification and release of finished product batch• Supervision of production in quality aspects• Handling of product complaints• QMS, product deviation, change controls, risk assessment• Employee training• QMS improvement

    • Validation Expert, Manufacturing and Science Department
      • May 2017 - Dec 2018

      • Cleaning validation• Manufacturing process validation• Equipment qualification • Risk Analysis

  • ZF Polpharma SA (PIW "IPOCHEM")
    • Quality Assurance Specialist
      • Nov 2010 - Apr 2017

      • Supervision of active substance manufacturing• Preparing dossier for API• QMS, APQR, audits, inspections• Quality Control • Supervision of active substance manufacturing• Preparing dossier for API• QMS, APQR, audits, inspections• Quality Control

Education

  • Medical University of Lodz
    Qualified Person Postgraduate Studies, Faculty of Pharmacy
    2019 - 2020
  • Warsaw University of Technology
    Master of Science in Bioprocess Engineering, Faculty of Chemical and Process Engineering
    2003 - 2009
  • Academy of the Internal Auditor of Integrated Management Systems
    Certified Auditor, ISO 9001, ISO 14001, PN-N 1800/OHSAS 18001
    -

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