Vanja Šušak Email and Phone Number

- ensuring continuous upgrading of the quality system with regard to regulatory requirements - writing SOPs and other necessary documents for obtaining a GMP license- writing PQRs- participation in employer projects- cooperation and organization of professional meetings- maintaining readiness for audits with the employer and and participating in writing audits reports

- all activities regarding stability and stability samples- development of stability testing protocols and reports

- defining stability studies in accordance with the approved stability test plan- management and care of samples for stability tests; activities related to specific tests such as freezing, cyclic test, in use, splitability- creation of characteristics, verification plans, strategy for stability testing in SAP system, preparation of reports on stability results of R&D products for different Teva locations - work in different systems: SAP, Glorya, EDMS, Quamas, Wisdom, Live Link, Lims6, Lims7, VG-LIMS- writing of stability declarations for customs within the department- preparation of documentation for inspections

- caring for stability chambers and rooms, reviewing alarm lists and histograms, reviewing logs for chambers and rooms in GASL- opening notifications, creating stability studies in SAP system

- monitoring control of changes, deviations, CAPAs, keeping all documentation in the archive, completing batch documentation for release, distribution of documents, participation in the preparation of documentation for process validation and validation in production, opening master data in SAPQuality Control - preparation of documentation in SAP for sampling of packing and starting materials, semi-finished and finished drugs, measurement and visual analysis of packaging materials and entry of results in SAP - monitoring and planning of stability samples, sampling of stability samples, conducting analyzes in the chemical-physical laboratory- sampling of purified water energy sources, environmental conditions of microbiological air samples, surface and handprints of workers