dibyendu das resume normal 041216

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Resume’ DIBYENDU DAS 1004 raj Tower Sec-18, Plot No-21, Kharghar-410210 [email protected] [email protected] Mobile: 09433109171/09699169360 AREA OF INTEREST Regulatory Affairs and Legal Associations. Medical Management: Procurement Management, Supply Chain Management Work Experience May 2016- Sep2016 Hemmo Pharmaceuticals Private Limited Microbiologist in Quality Control Department. Preparation of Drug Master files(DMF), New Drug Applications(NDA), Abbreviated New Drug Applications Preparing SOP and Documentations as per USFDA and ICH(International Council of Harmonisation). Dosseir Preperation and Dosseir Management. Common Technical Document (CTD) preperations. Microbial Environment Monitoring of controlled areas. Microbial testing procedure , MLT test, BET test, Growth promotion test. To perform the efficacy study and disinfectant study. Nov 2014–May 2016 ENALTEC LABS .PVT.LTD, MUMBAI . Quality Control Officer position, Regulatory Affairs positions. Regulatory Affairs documentations and DMF preparations. Common Technical Document (DMF) preparations. Techniques: Chromatography Techniques : HPLC,GC, Spectroscopy Techniques : UV spectroscopy, IR spectroscopy, FTIR. Specific Optical Rotation Method. Total Documentation Process as per GMP and cGMP. May 2013 –Nov 2014 SURAKSHA LABS NABL ACCREDATED LABORATORY Quality Analytics and Documentations. Quality analysis of the transcriptions Quality control Update the ISO guidelines and training. API and Formulations. Flow cytomtery in charge and Immunophenotyping technologist. Achievements CERTIFICATE OF EXPERT IN IMMUNOPHENOTYPING AND FLOW CYTOMETRY BEST EMPLOYEE IN SURAKSHA DIAGNOSTIC PVT LTD IN NABL AND CAP FINAL AUDITS Projects Done Immunophenotyping of acute leukemia a hospital based case study” to study the characteristics at different cases of acute leukemia patients. (1st may to 30th june 2012) To study of genotoxicity of leachates containing dyes pigments on swiss rattus(1st oct-1st march 2011) To study the chemical composition of leachates containing dyes pigments. To study the harmful and toxic e effects on swiss rattus To study the biodiversity and clinical utility of ocimum species throughout the India. (1st oct- 1st march 2011)

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Page 1: DIBYENDU DAS Resume Normal 041216

Resume’

DIBYENDU DAS1004 raj TowerSec-18, Plot No-21, [email protected]@gmail.comMobile: 09433109171/09699169360

AREA OF INTEREST Regulatory Affairs and Legal Associations. Medical Management: Procurement Management, Supply Chain Management

Work Experience

May 2016- Sep2016 Hemmo Pharmaceuticals Private Limited

Microbiologist in Quality Control Department. Preparation of Drug Master files(DMF), New Drug Applications(NDA), Abbreviated New Drug

Applications Preparing SOP and Documentations as per USFDA and ICH(International Council of

Harmonisation). Dosseir Preperation and Dosseir Management. Common Technical Document (CTD) preperations. Microbial Environment Monitoring of controlled areas. Microbial testing procedure , MLT test, BET test, Growth promotion test. To perform the efficacy study and disinfectant study.

Nov 2014–May 2016 ENALTEC LABS .PVT.LTD, MUMBAI .

Quality Control Officer position, Regulatory Affairs positions. Regulatory Affairs documentations and DMF preparations. Common Technical Document (DMF) preparations. Techniques:

Chromatography Techniques : HPLC,GC, Spectroscopy Techniques : UV spectroscopy, IR spectroscopy, FTIR. Specific Optical Rotation Method. Total Documentation Process as per GMP and cGMP.

May 2013 –Nov 2014 SURAKSHA LABS NABL ACCREDATED LABORATORY

Quality Analytics and Documentations. Quality analysis of the transcriptions Quality control Update the ISO guidelines and training. API and Formulations. Flow cytomtery in charge and Immunophenotyping technologist.

Achievements CERTIFICATE OF EXPERT IN IMMUNOPHENOTYPING AND FLOW CYTOMETRY BEST EMPLOYEE IN SURAKSHA DIAGNOSTIC PVT LTD IN NABL AND CAP FINAL AUDITS

Projects Done Immunophenotyping of acute leukemia a hospital based case study” to study the characteristics at different cases of

acute leukemia patients. (1st may to 30th june 2012) To study of genotoxicity of leachates containing dyes pigments on swiss rattus(1st oct-1st march 2011) To study the chemical composition of leachates containing dyes pigments. To study the harmful and toxic e

effects on swiss rattus To study the biodiversity and clinical utility of ocimum species throughout the India. (1st oct-1st march 2011)

Page 2: DIBYENDU DAS Resume Normal 041216

Resume’

Education

2011- 2013 University of Kalyani (60%)Master degree in Molecular Biology and BiotechnologyFlow cytometry ,PCR RTPCR , ELISA HPLC, GC Immunophenotyping Genetics,GMO, API,CGMP

2008 - 2011 West Bengal University of Technology (72%)Bachelor degree in Biotechnology.Molecular biology cell biology Plant/Animal Biotechnology Biochemistry and Organic chemistry Tissue culture technology Genotoxicity studies and genome typing

2005-2008 SSE(59%)Senior Secondary education, Pure SciencePhysics Chemistry Organic chemistry Mathematics Biology Cell, human anatomy.

2004- 2005 HS(65%)Higher Secondary SchoolScience Mathematics

Additional skills

LANGUAGESEnglish (fluent), Hindi (fluent), Bengali (native), Marathi (proficient).

ITMicrosoft Word (expert), PowerPoint (expert), Microsoft Excel (advanced),NetBIOS (basic).

STRENGHT Good observer, sincere and hard-worker. Ability to communicate with people successfully-always gives priority to senior. He made them realize that not senior

they can do the job and now made good relationship. Ability to adopt any new skill successfully-NABL project & CAP Project. Ability to learn and adapt in multicultural environment -was not able to manage new place & high level of travelling now

adopted and it is OK. Not a problem. Good analytical, problem solving skills and leading abilities.

I hereby affirm that the information in this document is accurate and true to the best of my knowledge.

Date: Signature.