Experience

Erba Lachema s.r.o.

• Czechia
• Biotechnology Research
• 1 - 100 Employee

• Regulatory Affairs Specialist

  • Oct 2020 - Present

  Compilation of product technical files in English language in compliance with the EU legislation. Cooperation with departments within and outside the company. Compilation of product technical files in English language in compliance with the EU legislation. Cooperation with departments within and outside the company.



Synthon

• Netherlands
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Researcher

  • Apr 2019 - Sep 2020

  Sample analysis with HPLC, method prevalidation Preparation of samples and imaging with SEM (Scanning electron microscope) Electroanalytical methods - Potentiometry Writing of reports Sample analysis with HPLC, method prevalidation Preparation of samples and imaging with SEM (Scanning electron microscope) Electroanalytical methods - Potentiometry Writing of reports



Sandoz GmbH

• Austria
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Associate Scientist

  • Dec 2018 - Mar 2019

  Analysis of protein samples, method developmentDocument review and approval

• Senior Technician - Technical research and development

  • Jan 2017 - Nov 2018

  Analysis, evaluation and documentation of protein samples with HPLC, SDS-PAGE and ELISAMethod development and optimizationWriting of reportsApprentice trainerSAP usage

• Lab Technician - Quality control

  • Sep 2014 - Dec 2016

  Purity and assay determination of APIs and raw material with HPLC and GC.Evaluation and documentation of analysis in compliance with GMP regulations. Following of SOPs.Organizing and planning of daily tasks.Transfer of analytical methods.Maintenance and qualification of the analytical instruments.