Barbara Pietrus

QC Microbiology Expert at Polpharma Biologics
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Contact Information
Location
Gdańsk, Pomorskie, Poland, PL

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Stephan Smith

Barbara has an excellent ability to plan, execute her work to a very high standard consistantly whilst also being able to impart her knowledge to team members and develop them to work to a high quality standard. She was always pramatic and able to deal with the day to day issues that came up. She effortlessly managed the completion of the days tasks whilst enganging the team to assist or stay late if required due to loyalty and trust she developed with them. She is very patient and a good listener. She has expert knowledge of QC Micro techniques especially endotoxin testing a problem sloving issues with the testing. A kind and approachable colleague who provided brilliant support to me whilst I got up to speed with the department and team. Thanks Barbara.

Sallyann Connor

I had the opportunity and pleasure to work with Barbara at Lonza Biologics (Slough). Barbara is a first class Microbiologist with a vast technical knowledge, which includes a technical and practical knowledge of the endotoxin assay. Barbara was a much liked member of the Microbiology team and a go to person within the team. She is able to work as a team player but can also work independently on assigned projects such as customer protocolled studies with minimal guidance. I would very much like the opportunity to work with Barbara again in the future.

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Experience

    • Poland
    • Biotechnology Research
    • 700 & Above Employee
    • QC Microbiology Expert
      • Jul 2017 - Present

      • Participation and preparation of audits/inspections (FDA/GIF) • Audits of third parties such as external suppliers to ensure their quality • Conducting and supervising of deviations, change controls, CAPA’s, OOX investigations, risk analysis • Development, review and approval of microbiological procedures, validation documentation and testing methodology • Preparation of documentation for Biologics License Application (BLA) • Analytical method transfer, project supervision in the scope of transfer change control, documentation, training, testing execution • Point of contact for microbiological projects, collaborating with internal and external stakeholders • Development and review of product testing strategies and sampling process plans in the scope of microbiological control • Supervision over the implementation and validation of microbiological methods and support of product process validation • Supervision over performance of microbiological analyses based on the guidance of GMP, Eur.Ph., USP-NF, local procedures, and specifications in the scope of raw materials, IPC, and finished products Show less

    • Switzerland
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • QC Senior Scientist
      • Jun 2009 - Sep 2016

      • Leading the microbiological method verification testing team • QC Customer Representative for Kolltan Pharmaceuticlas • Investigation and completion of quality records including deviations, OOX, environmental excursions and CAPA’s • Writing/reviewing of analytical methods verification protocols/reports • Performing routine microbiological tests in QC laboratory (bioburden, endotoxin (KCA), microbial identification (MicroSEQ ID System), media growth promotion tests, and environmental monitoring • Environmental data interpretation, preparation of environmental data trends • Endotoxin testing system administrator Show less

    • United Kingdom
    • 1 - 100 Employee
    • Senior Analyst/ Team leader
      • Jul 2005 - Jun 2009

      • Scheduling and prioritizing workload in Microbiology laboratory and in sample reception • Microbial analysis of water samples (the Bioburden and Endotoxin test using the Kinetic Chromogenic Method), Identification of microorganisms • Environmental Monitoring • Scheduling and prioritizing workload in Microbiology laboratory and in sample reception • Microbial analysis of water samples (the Bioburden and Endotoxin test using the Kinetic Chromogenic Method), Identification of microorganisms • Environmental Monitoring

Education

  • Birkbeck, University of London
    Master of Science - MS, Microbiology
  • The George Washington University
    Project Management Essentials
  • The University of Manchester
    Pharmaceutical Industry Advanced Training (PIAT) - Appliction of Microbiology in Biopharmaceuticals
  • University of Wroclaw
    Bachelor of Science - BS, Biotechnology
  • ICAN Institute
    Manager's Academy

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