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[QUOTE=Guest;146553]RESUME [b]Name [/b]: Soham B. Oza [b]E-mail [/b]: sbopharma11 AT yahoo.com [b]Career Objective [/b]: To work in a globally competitive environment on challenging assignments that shall yield the benefits of job satisfaction and a steady paced professional growth, possessing competent technical skills while being resourceful, innovative and flexible. [b]Area of Interest [/b]: Internal Quality Assurance, Research Quality Assurance , and Corporate Quality Assurance, Regulatory Affairs, Formulation & Analytical Dept [b]EXPERIENCE [/b]: 1)AS PRODUCTION OFFICER J.B.PHARMACEUTICAL [b]From [/b]: Feb 2010 to May 2010. 2)WORKING IN SUN PHARMACEUTICAL IQA PHARMACOKINETIC DEP [b]Snap shot of the Experience [/b]: At Present, I am working with Research Center of Sun Pharmaceutical Industries Limited based at Baroda, Gujarat since 1st june 2010 till date in Internal Quality Assurance (Bioanalytical -QC ) wing of Pharmacokinetics Department. [b]Current Job Profile includes [/b]: - Review of raw data & chromatograms of Bio Analytical Studies generated by Mass Spectra. - Raw data review & checking chromatography thoroughly & also checking GLP Compliances in the generated data. - Report review of submission studies for its Absorption & Elimination Pattern to Regulatory Authority such as USFDA, ANVISA, CANADA, EUROPE, etc. - Handling of Deviations and Non-Compliances in the Data. [b]- Bio-Analytical [/b]: checking stability data of Method validation & Partial Method Validation Data throughly. [b]- Pharmacokinetic [/b]:Repeat identification from the generated data & finalising the concentration data of subjects for its statistical evaluation such as C MAX, AUC, T MAX etc. - Reviewing the report tables that are generated from WIN NOLIN soft ware. - Preparation of system related standard operating procedure. - Brief Description of the Organization Pharmacokinetics Dept. of Sun Pharmaceutical Industries Ltd.,Baroda & compiles the Bioanalytical, Clinical and PK raw data and reports for bioequivalence studies intended for submission to Regulatory authorities of USA ,EUROPE, CANADA, AFRICA & BRAZIL. [b]Audits faced [/b]: (1) EMEA (EUROPE) ( 2 ) DCGI ( DELHI ) 3) USFDA [b]Educational Qualification [/b]: Examination School/College Percentage SSC Gujarat State Board 74.86% HSC Gujarat State Board 44.00% First Year D.Pharm Sanjivani,Kopargaon 58.00% Final Year D.Pharm Sanjivani,Kopargaon 67.90% Second Year B.Pharm M.G.V.’s Pharmacy College ,Nashik 53.25% Third Year B.Pharm M.G.V.’s Pharmacy College ,Nashik 55.04% Final Year B.Pharm M.G.V.’s Pharmacy College ,Nashik 57.58% [b]Industrial Training [/b]: In Liva pharmaceutical nashik [b]Language Known [/b]: English, Gujarati, Hindi, Marathi [b]Computer Skills [/b]: - Basic computer skills - knowledge of Microsoft Office [b]Achievements [/b]: - Distinction in University project “Organ function test”. [b]Extra-Curricular Activities [/b]: - Chess, Cricket[/QUOTE]