Gökay Mutlu Öz Email & Phone Number

Slovenia

Ljubljana, Slovenia

- Leading the whole project until the licensing and launch of 3 molecules in the company within the scope of the BD&L project- To lead as project manager for the project of production with new and alternative API sources- Lead, implement, and report on global AS&T requirements/programs in the network- Supports defining and implementing business processes.

Gebze

Transfer&Validation- Internal and external project management and transfer activities- Manage the saving and development projects and presentation the reports- Support and perform regulatory requirements - Communication with external and internal customers directly with regard to process- Root cause analysis with Change Control and following up actions..

Gebze

- Internal and external Transfer activities. - Training records, provide suitable training programs for new workers- Preparation of Analytical Method Validation Master Plan- SOP’s revision and conformity with QM Module- Performance management for 5 direct repports

Luleburgaz

- Manage release and stability analyses and transfers with GLP methods- Evaluate performances of Specialists and Assistant Specialists- Monitored calibrations and validations of the devices and softwares. Invention a new system worth 800.000 €/y in laboratory on HPLC system- Preparation of training plans and performance management for 8 direct reports.

Luleburgaz

- Analytical Method Development, Stability and Quality Control tests according to ICH Guideline- Analytical development and validation project worth 5 milyon €- Development and validate of analytical cleaning methods. Taking FDA certificate for analytical cleaning validation tests.- Method transfer to the Quality Department from Development Dept.

2,9, Mba

Activities and Societies: MARKETING-MANAGEMENT SECTION

Chemical Engineering Technology, Master Of Science

2,6, Chemical Engineer

Public Relations, Advertising, And Applied Communication