Anıl Urenay

-Development and validation of new analytical methods with HPLC,AAS and GC for new product lines in a GMP laboratory.Using Waters Empower and Shimadzu Lab Solution Softwares. -Assay and impurities methods -Pharmacopeia Tests (USP and EP) -Performing and carrying out a variety of routine analytical techniques including but not limited to HPLC, GC, UV, pH, Colour, Osmolality, Degree of Coloration and Appearance in compliance with GMP requirements

-Operating Waters LC-MS/MS, Agilent GC-MS/MS and Agilent HPLC devices.(Replacement of coloumns, frits, liner,o-ring,septa ,cleaning ion sources) -Developing, standardizing, evaluating procedures and techniques for residue tests used in the analysis of specimens with LC-MS/MS,GC-MS/MS and HPLC. .-Supervising and managing 4 workers.

-Controlled and evulated SOP/Validation Reports according to ,FDA,ISO 17025 ,ICH and EU regulations.(Specifity-Linearity-Accuracy-Precision(Repeatability-Reproducibility)-Detection Limit-Quantitation Limit-Robustness) -Developed process to screen, interview, hire, train, and maintain staff competency. -Developed, standardized, evaluated procedures and techniques for GMO tests used in the analysis of specimens with Real-Time PCR.

-Created Standard Operating Procedures (SOP) according to FDA,ISO 17025,EU regulations. -Performed validation and internal/external audit as well as wrote and updated SOP/Validation Reports according to FDA,ISO 17025 ,ICH and EU regulations.(Specifity-Linearity-Accuracy-Precision(Repeatability-Reproducibility)-Detection Limit-Quantitation Limit-Robustness) -Operated and troubleshot independently Thermo brand five analytical machines : GC-MS/MS,LC-MS/MS,HPLC-FLD/DAD,ICP-MS,GC-FID

-Performed validation and internal/external audit according to FDA,ISO 17025 ,ICH and EU regulations.(Specifity-Linearity-Accuracy-Precision(Repeatability-Reproducibility)-Detection Limit-Quantitation Limit-Robustness) -Operated LC-MS/MS,HPLC,GC-MS/MS