Renata Sobieska-Żołądkiewicz

Senior Development Specialist at BIOTON S.A.
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Contact Information
us****@****om
(386) 825-5501
Location
Piastów, Mazowieckie, Poland, PL
Languages
  • English Professional working proficiency
  • German Limited working proficiency

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Credentials

  • Process Scale-up, Validation and Technology Transfer for Biologics
    Symmetric Training (Professional Training & Coaching) - and click on the logo of our company
    Mar, 2022
    - Nov, 2024

Experience

  • BIOTON S.A.
    • Poland
    • Biotechnology Research
    • 100 - 200 Employee
    • Senior Development Specialist
      • May 2020 - Present

      ● Preparation of technological and registration documentation, e.g. technological documentation: manufacturing batch records, process description for diabetic products, CTD module 3 as part of ongoing projects in accordance with the guidelines EMA / FDA ● Performance of activities ensuring quality and safety of the drug products. Active support of the Operational Quality Assurance Department. Investigation Report, CAPA schedule preparation● Initiation and oversight of the change control process. Preparation of the application for a change according to SOP-standard operating procedure ● Participation in the implementation of changes in research and development projects in order to improve the quality of manufactured medicinal products in accordance with GMP guidelines, e.g. modification of sterile filtration system, technology transfer of drug product, scale-up processes implementation● Participation in audits, cooperation with external companies● Ability to analyse and interpret the obtained analytical data, e.g. stability data analysis, comparability studies Show less

    • Deputy Responsible Person
      • Jul 2018 - Present

      ● Performing the duties of the Responsible Person at pharmaceutical wholesaler, working in accordance with GDP requirements● Pre-evaluation of quality-relevant deviations during storage and transportation, delivering● Cold chain and storage temperature monitoring● Maintaining the required records of complaints● Representing the company in the audits of the Pharmaceutical Inspection bodies

    • Acting Product Development Manager
      • Oct 2018 - Apr 2020

      ● Supervision of a project, implementation and working in accordance with EMA / FDA guidelines, e.g. technology transfer also to external companies● Supervision over the risk analysis preparation ● Conducting research in accordance with the EMA / FDA / WHO guidelines; using the available literature, scientific and patent databases● Analysis of current indications, guidelines for the pharmaceutical industry (PDA Journal, PIC's, ISO standards)● Planning and monitoring of the budget for implemented projects Show less

    • Pharmaceutical Technologist
      • Mar 2012 - Sep 2018

      ● Supporting the Operational Quality Assurance Department in the estimation of API quality● Verification of cleaning processes and risk analysis preparation connected with manufacturing optimization● Scheduling of stability testing preparation (long-term, accelerated, stress, photostability, in-use tests) according to ICH guidelines. Monitoring and verification of these studies, reports preparation● Preparing comparability reports, estimating physico-chemical parameters between RMP and manufacturer product. Preparing specifications for new products or materials Show less

  • Bioton S.A
    • Woj. Mazowieckie, Polska
    • QPPV deputy, additional function
      • Nov 2012 - Aug 2019

      ● Verification and substantive evaluation of reported complaints ● Cooperating with Operational Quality Assurance Department ● Pre-evaluation, processing CAPA, deviation protocols ● Knowledge of GVP requirements ● Preparation of adverse event / adverse reaction reports in accordance with SOP ● Verification and substantive evaluation of reported complaints ● Cooperating with Operational Quality Assurance Department ● Pre-evaluation, processing CAPA, deviation protocols ● Knowledge of GVP requirements ● Preparation of adverse event / adverse reaction reports in accordance with SOP

  • Department of Drug Chemistry and Pharmaceutical Biotechnology, Warsaw Medical University
    • Warszawa, Woj. Mazowieckie, Polska
    • Assistant Researcher
      • Aug 2000 - Sep 2008

      ● Classes with students on chemical synthesis and fungi biotechnology ● Biosynthesis of mycelial culture optimizing in bioreactors ● Scientific literature databases overview and publications preparation ● Classes with students on chemical synthesis and fungi biotechnology ● Biosynthesis of mycelial culture optimizing in bioreactors ● Scientific literature databases overview and publications preparation

  • Institute of Pharmaceutical Biology
    • Rejon Kolonia-Bonn Germany
    • Scholarship Holder
      • Oct 1999 - Aug 2000

      ● Research work with a group of maytansine compounds using HPLC and bioengineering methods ● Analysing literature database and preparing scientific publications ● Research work with a group of maytansine compounds using HPLC and bioengineering methods ● Analysing literature database and preparing scientific publications

Education

  • Medical University of Warsaw - MUW
    Pharmacy specialist, Postgraduate studies
    2008 - 2010
  • Warszawski Uniwersytet Medyczny - WUM
    Master's Degree in Pharmacy, Industrial pharmacy
    1994 - 1999

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