Dipl.-Ing. Volkan Açıkgöz

•Support in software testing and computerized system validation as a CSV expert (CS, OQ, PQ) •Support MES and BioMES implementation projects •Support MBR design within Werum PAS-X software •Support MES full EBR roll-out period •Support LIMS implementation projects (HP ALM, LabVantage) •Support Go-Live and hypercare periods •Support MBR, EBR, GMBR, PVL, BOM design •Support key user and end user trainings •Support quality related projects for validation with QA and DI perspective

•Leading MES KPI Project •Leading MES Historian Project •Leading GMBR standardization and Review by Exception project •Responsible for QA and DI projects •Leading Werum MES PAS-X 3.1.8 update project •Leading MES Full EBR 2. phase roll-out project •Leading internal & external project team members based on project schedule and training •Tracking overall project costs based on approved project budget

•Preparing the 2. phase roll-out plan of Novartis Kurtkoy MES Full EBR Project •Tracking overall project costs based on approved project budget •Leading the MBR Designer Team to create and maintain the site MBR by providing required training and management •Support MES MBR Design for deployment of Global MES Template (GMT) based on MES PAS-X 3.1.7 at Novartis Kurtkoy site •Responsible for designing Weighing and Dispensing, Solid Bulk Manufacturing and Packaging (G)MBRs

•Responsible for designing Weighing and Dispensing, Solid Bulk Manufacturing and Packaging (G)MBRs by using localized MDEs based on site requirements •Providing master data of the system configuration •Leading MBR/EBR management SOPs •Providing the key user trainings before Go-Live •Designing MBRs and GMBRs during the project and operation •Supporting preparation of OQ&PQ test scripts and execute related validation tests •Train and support other MBR designers •Supporting Go-live period

•Responsible of Dispensing, Granulation and Tabletting processes complies with GMP and HSE regulations •Supporting preparation of weekly manufacturing plans and ensure execution of production schedule •Managing all operators, prepare shift arrangements and overtimes and supervising the team to meet with success at the performance target of the department •Preparation of annual departmental training scheme •Preparing unit SOPs/MBRs and make the revisions •Preparing deviation and change control records

•Responsible of liquid packaging process •Supporting preparation of weekly manufacturing plans •Managing all operators, prepare shifts and overtimes •Monitoring performance of packaging lines, preparing daily performance •Preparation of annual training plan •Supporting installation and implementation of 2D System •Responsible with adaptation of new products&alternative packaging materials •Preparing unit SOPs&MBRs •Preparing deviation and change control records •Follow up packaging designs

•Responsible for all liquide sterile and aseptic production processes •Responsible for liquid packaging operations •Following production plan •Shut down/Start up period planning •To produce drugs in accordance with the GMP and HSE rules •Process improvement of all products •Leading of all manufacturing operations and operators •Quality Modules and GOPs management •Leading IPC processes in shifts •Managing Change Controls and Deviations •Managing investments and all production activities