Aylin Ibrahimoglu

- Compile, prepare, review and submit regulatory submission to domestic and foreign health authorities - Prepare GMP inspection submissions and follow up certification process - Submit and review change controls to determine the level of change and consequent submission requirements - Artwork preparation and coordination for existing and portfolio - Review regulatory aspects of contracts

- Analytical laboratory assignments and activities to meet established project goals and timelines - Perform analytical method development and execute method validations and method transfers - Prepare and review technical documents, including validation protocols and reports, analytical test procedures and change controls - Provide the necessary documentation for regulatory submissions, review submission documents and write deficiency responses.

- Perform instrumental analysis of finished products for release and stability - Prepare and assess standards and solutions - Implement standard operating procedures - Perform scans and data reviews - Evaluate test results compared to historical data for trend analysis