Maja Rafaj

Documentation management Change control management Quality management process for vendors Quality agreements Internal audits Corrective / Preventive actions (CAPA) Quality risk management

Responsibilities: Validation, development, transfer from site to site and revision of HPLC analytical methods for final dosage forms and APIs Verification and comparison of pharmacopoeias methods Author of method validation/verification/transfer protocols and reports Author SOPs, new analytical methods, specifications Change control - Trackwise Documentation - Glorya EDMS Troubleshooting and qualification of HPLC instruments

Responsibilities: Analysis of raw materials, in-process materials and finished products according to approved SOPs in compliance with GMP/GLP regulations (HPLC, GC, UV/VIS, Kjeldahl, etc.) Method development, optimization, qualification, and validation. Author SOPs and new analytical methods. Troubleshooting, qualification and validation of laboratory instruments and methods.

Automatization developer on IPA (Instrument for Pre-Accession assistance) project “Rapid Identification of Cells in a Clinical Environment – RapidCell”. Research and development of the novel biotypisation method using LC-MS and developing computer software using various biochemical analysis using 2-D gel electrophoresis, HPLC, CapLC, UPLC, mass spectrometers MALDI TOF/TOF and ESI-Q/TOF.

I have worked at the “Ruđer Bošković Institute”, Center for Proteomics and Mass Spectrometry as working associate and volonteer. Using various bioanalytical methods for protein isolation (2-D gel electrophoresis, HPLC, CapLC) and peptide sequencing (mass spectrometer MALDI TOF/TOF) I have worked on the research and development of the novel biotypisation method and developing computer software.

Through the CK-CARE Visiting Fellowship, I had opportunity to work at the “Swiss Institute of Allergy and Asthma Research“ as a laboratory researcher. I had worked on project "T cell regulation and T cell tolerance" which main aim was to identify new genes and proteins that may play a role on severe asthma. I have gained work experience in PCR, quantitative realtime PCR, Bio-Plex, ELISA, flow cytometer, cell culture,cloning techniques and in vivo animal experiments.