Matyushkina Natalia

QA activities in the pharmaceutical distribution company: GDP procedures, audits, personnel training, CAPA, Deviations, Change Control.

Developed, implemented and maintained Quality Management System in the LLC “Raifarm”. I conduct preliminary inspections (mock audit) for compliance with GMP requirements at foreign manufacturing sites producing medicinal products. I accompany inspectors during fficial inspections, assisting in communication with the plant employees and inspectors. I carry out consultations on the current procedure for preparing and conducting inspections of a foreign manufacturer. Together with the manufacturer I prepare and coordinate the submission of the package of documents to the Ministry of Industry and Trade of Russia. I assist in the preparation of responses to the inspector`s observations (CAPA) on the results of previous inspections. I consult on the current procedure for medicine registering, changes to the registration dossier and / or documents, development of a strategy for preparing a dossier for submission to the Ministry of Health of the Russian Federation and regulatory authorities of the EAEU countries for foreign pharmaceutical companies. I prepare documents for the registration dossier, including administrative documents, regulatory documents, packaging mock-ups in accordance with the current legislation for subsequent submission to the Ministry of Health of the Russian Federation.

Analitcal test for protein manufactoring, SOP, provide GMP documantation and Risk Analysis.

Alphamab Co. is a bio-technology company focusing on the researches and developments of therapeutic antibodies as well as other recombinant protein medicines.

Test for Clinical trail phase ǁ and ǁǀ, provide regulatory documantation.