Quality Specialist
CurrentAs Quality Specialist in Xellia I am responsible for R&D projects as Quality member of the team. In that role I review supplier's documentation and evaluate if it is in compliance with relevant quality standards (pharmacopoeias, guidelines, etc.) and approve potential supplier based on adequacy of documentation, I prepare specification proposals for starting materials (active substances and excipients), primary packaging materials and finished products. I approve technical transfer documentation of finished dosage form, cooperate with R&D team in review and evaluation of suitability of results of trial batches, approve all technology transfer documents in line with company's standard operating procedures, review and evaluate analytical documentation (validation protocols, reports and final methods) to ensure compliance with current quality standards. In case of deviations I ensure they are fully investigated and documented, and CAPA measures implemented. Working in this role means I have significant knowledge of ICH, US, and EU guidelines and experience in sterile operations according to EU and FDA standards.
