Deren Dogru

Implementation of GMP Concepts

Responsible for coordination of all change related activities. Responsible of preparing quality agreements and contribute to other contracts (production, trade etc.) Acts as the deputy of the GMP (Good Manufacturing Practices) Coordinators and Regulatory Specialist. Responsible from organizing site’s training activities, primarily the QA department.

Responsible for the yearly planning of product and process Validation Master Plan and execution of the validation studies. Responsible for review of production & packaging processes and approves the relevant protocols Responsible for planning of the qualification program of all analytical equipments Responsible for planning the Cleaning Validation activities in cooperation with the Production and the Planning Departments.

Responsible for formulation, method development & validation of Generic Drugs Participated in FDA (Food&Drug Administration) Projects

Led various research on oxygen isotope ratio analysis of phosphates; geochemical separation of inorganic and organic phosphate; designing/modifying various methods; extraction of the organic matter from core samples

Participated in various research on collection of marine water and sediment samples; geochemical analysis of sediments and sediment pore waters; benthic organismal sample preparation, identification, and analysis; and GIS mapping and interpretation of data using a variety of techniques and instruments

Participated in the Lower Quinnipiac River Corridor GIS-Project and Hamden Brownfields Redevelopment 3D GIS-Project

Certificate in Geographic Information Systems (GIS)