neda misic

* Worked on Sterile Water for Injection (WFI) control site within the Department for making infusions and arterial medications * Active support for Production Department including monitoring of process conditions and troubleshooting * Included in planning working progress presentations

* Responsible for testing of final product and stability samples within Final Product Testing Laboratory(QC) * Working daily on execution of different testing procedures, HPLC, gel and bio assays, product release documentation, methods optimization, troubleshooting and managing new SOPs * Expert for HPLC assays (i.e. deamidation, peptide mapping, SEC, oligosaccharide) * Involved in Methods Transfer – piloting new assays(HPLC, electrophoresis, bio assays) * Responsible for results assessment and investigations in case of deviations * Working in the GMP environment according to GMP regulations * Experienced with : * ETS (Event Tracking System), Track Wise deviation system , * LIMS system(Global Laboratory Information Management System) * SAP (System and Application Products) system

* Pro-active cooperation with the AD sub-CMC team and PDMS functions to facilitate successful project execution and achievement of key deliverables / communication with QI/QO/TI * Coordination of all analytical methods transfers / validations * Managing Stability studies * Single point of contact for assigned products * Lead of investigations related to the product * Escalation of stability related issues * Coordinate preparation / update of stability and regulatory related Quality Agreements * Providing regulatory support for filings and filing updates (IMPD,IND,BLA,EMA,Type II variations). * Follow-up / handling of regulatory questions related to stability * Input and writing of stability sections of eCTD * Prepare regulatory inspections with regard to stability topics * Participate in projects as stability expert * Manage changes of shelf life / retest period and storage instructions