Leonid Durosov

- Product release: review of documentation (deviations, batch records, change controls, etc), generation of reports and SAP activity; - Evaluation and approval of routine change control, complaints and deviations; - Annual Product Review scheduling and review; - Developing areas of focus for audits and inspection support of external partners; - Collection and compilation of KPI data.

- Conduct of medicines manufacturers inspection on compliance with GMP rules; - Preparation of inspection reports and expert opinions.

- Coordination of the analytical service group, including the planning of specialists work; - Ensuring timely preparation of Certificates of analysis for compliance with time limits for release of incoming materials, bulk and finished products; - Control over the processes of development of specifications, SOPs and other QC-relevant documentation; - Management of Artworks for packaging materials; - Creation and review of stability testing protocols.

- Development of standard operating procedure, specifications and other GMP- and quality documentation; - Development and coordination of stability testing programs in accordance with ICH, EudraLex, WHO requirements, result recording, development of stability reports with trend analysis; - Activity in SAP-System

- Ensuring compliance with technological processes - Investigation of complaints - Checking the accuracy of equipment - Organisation of trainings

- Performance of analysis on Time of Flight Secondary Ion Mass Spectrometer (TOF.SIMS 5); - Analysis methods development; - Creation of investigations reports and analysis reports