Omer Faruk FIRAT

* Strategic Planning, analysing current situation, assessing needs, establishing goals, determining strategy and responsibility, measurable targets,
* Prioritization; for time management and prioritization of daily works and projects,
* Patent Evaluation, for patented products and developing non-infringing products,
* Preparation of Technical Reports, for authorities and government supports such as Tübitak funds,
* Regulatory Query Responses, for responding letters from national and international authorities,
* Troubleshooting, for the life-cycle of products and improving the processes of commercial products,
* Strong Track Record, for audits of national and international authorities and customers,
* Highly motivated and Team Leadership, acting as a member of project team,

• Evaluation of the projects and requirements for successful transfer from one site to another site, with encountering the trouble shooting smoothly.
• Performing team leadership, directing to colleagues and subordinates for project management and special complex product development.
• Delivering continued success in achieving and exceeding company goals and objectives in the form of First Generic Projects.
• Effectively defining and implementing targeted action plans to maximize operational productivity.
• Provide guidance and review responses to regulatory queries for submitted products.
• Dealing with international clients/collaborators for the development/co-development of various projects.

• Generic Product Development, including Process Validation Protocols and Reports.
• Scale-up activities from R&D Scale to Commercial Scale

Generic Product Development, including Process Validation Protocols and Reports.
Scale-up activities from R&D Scale to Commercial Scale, in coordination with Quality Operations.
Process Improvement & Optimization for Commercial products.
Cost saving activities & Process Development for Commercial products.

• Generic Product Development steps;
• Analytical Method Validation
• Manufacturing Process Development
• Process Validation Protocols and Reports.
• Scale-up activities from R&D Scale to Commercial Scale.
• Regulatory & authority documentation