SPSFAM_Sugar_ERP-92018Proposal

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Bulk Drug  In- Process Control Methodologies for Intermediates & Finished Products

 Implementation of All QA norms applicable to API Industry- Deviations, Change controls, IQA, Customer Complaints, and Validations etc. Total Process Control (Analytical) on HPLC for 7- ACCA Production in Plant  Standardization of HPLC Methods for Intermediates and Finished Products Viz. 6-APA, 7-ADCA, MAEM, TAC, ACACY and Cephalosporin: Cefalexin, Cefadroxil, Cefradine, Cefixime trihydrate, Cefuroxime Axetil, Cefuroxime Acid, Cefotaxime acid, Ceftrioxone Disodium, Cefazolin Sodum Cephalothin Acid, Cefoperozone Acid, Ceftiofur Acid.  Semi-synthetic penicillin : Ampicillin Trihydrate, Ampicillin Anhydrous etc  Standardization of GC Methods for analyzing Various Solvent Residues / Recovery Streams Viz. MDC/HMDO, Toluene / HMDO, Ethylacetoacetate, Methylacetoacetate, Ethyl acetate / THF, DMF, Acetone etc.  Environmental Monitoring: Analysis of Water & Wastewaters, Soils & Industrial Sludges & Analysis (About 200 Physico - Chemical Parameters and organic parameters as per USEPA and WHO).  Water Quality Monitoring (Surface, Ground, Estuarine, Sea-Waters) Achievements at Vimta :  Actively engaged for the Growth of Trace analysis laboratory in Vimta for its Global Reputation  Responsible for setting up of full-fledged Mass spectrometry Lab in Vimta (range of mass spectrometers from Single Quadruple to High resolution mass spectrometer)  Completed around 100 Method developments and Validation in various fields like Bulk drugs, Trace analysis, Ultra trace analysis and Bio analytical fields  Ultra-trace level analysis by using High resolution mass spectrometer WATERS AUTOSPEC. May 1995 to June 1998 Scientist – Analytical, Vimta Labs Ltd., Hyderabad, India

Bio-Analytical :

 Engaged in the area of Bio-analytical method development/validation as per US-FDA guidelines  Successfully completed a critical project for simultaneous determination of two anti- hypertensive drugs (Isosorbide dinitrates and its metabolites and Hydralazine) in blood plasma involving derivatization and detection with different instrumental techniques  Pivotal in the development and validation of over 10 assays using plasma and serum as the bio- matrices using GC-MS/MS instruments  Leachable and Extractable:

 Developed the capability for testing Leachables and Extractables  Supported the Pharma majors in Leachable and Extractable projects

Phone - +91-7680003040 , +91-040-27136211 (R) E-mail:- yadlapallii@hotmail.com ;