Karolina Kozupa

- Overall responsibility for complaint management in a GMP-regulated environment - Responsibility for supplier qualification and evaluation (audits, approval processes) - Management, assessment, and GMP-compliant documentation of OOX cases - Conducting internal inspections

- Review of studies for compliance with regulatory requirements under GLP (Good Laboratory Practice) and ISO 17025. - Conducting internal inspections. - Maintenance and optimization of the quality assurance system (deviation management, CAPA, change management, review of equipment and validation documentation). - Conducting quality assurance-related training. - Creation and updating of SOPs and controlled forms. - Administration and support of the document management system (EtQ Reliance ).

- Conducting analytical methods in an accredited laboratory (determination of VOCs/BTEX, hydrocarbon index, PCB using GC-MS, GC-FID), - Evaluation and documentation of results (LIMS), - Optimization and development of new analytical methods.

- Study Director for GLP studies in the area of biodegradability. - Implementation and optimization of test methods. - Determination of TC, TOC, and TIC parameters. - Elemental analysis of liquid and solid samples. - Determination of physicochemical parameters.

Determination of PLFA in soil samples using GC-MS technique, Determination of enzyme activity of microorganisms in soil samples using UV/VIS technique