Management Regulatory

Curriculum Vitae

Mr. DATTA ASHOK CHAVAN.

*, *********** *** *****,

behind church, near Wadala-

pathardi road, Indira nagar,

Nasik, Maharashtra, pin-

422009.

********@*****.**.**

********@*****.***

Objective:

To develop my career in the field of Pharmaceutical in a professional

environment that provides an opportunity for growth.

Professional Experience: -

* I worked with Ranbaxy Laboratories Ltd as Senior Research Chemist

since May-12th 2005, to 18th Nov 2013.

* Worked in Noble Drug's Ltd. (ISO 9002) as Chemist in QA/QC since 22nd

Sep 2003 to Apr 2005.

Area of interest: Drug Regulatory Affairs.

Pursued Advance Post graduate Diploma in Regularity Affairs (API &

Formulation) from 'Institute of Pharmaceutical Management', Dombivli

Course Syllabus:

* Introduction to RA profession

* ICH Quality guidelines - Q1,Q2,Q3, Q6

* GMP overview w.r.t Eudralex & ICH guidelines, Change control

* DMF preparation in CTD format

* API-Regulatory submissions to USFDA, changes to DMF

API-Regulatory submissions to EDQM & EMEA, revisions

and renewals

API-Regulatory submissions to WHO, Canada and Japan

* Handling deficiencies w.r.t. above submissions

* Dossier preparation in CTD format

* Regulatory Systems in US, ANDA submissions, handling post approval

changes

* Regulatory Systems in Europe, filing procedures, handling variations

* ACTD submissions

* Handling deficiencies from Drug Regulatory

Authorities w.r.t. above submissions

* eCTD submissions

* GMP audits

* Patents from regulatory perspective

* Polymorphism from regulatory perspective

Job Responsibilities in Ranbaxy Lab. Ltd.:-

* Worked in Impurity Profile Department which is a part of process

department.

* Synthesis/Purification of desired impurities.

* Synthesis of In-house impurities & pharmacopoeial impurities. (EP &

USP).

* Synthesis of metabolites for Bio-Equivalence study (Generics).

* Generating the material for toxicity of impurities.

* Purification of the different impurities by using columns

chromatography.

* Identification/Elucidation of probable/proposed structure for

impurities/ metabolites present in API, Formulation Drug & Stability

samples by using LC-MS analysis & HPLC.

* Literature searching for probable structure of impurities through

manual & internet.

* Characterization of the synthesized impurities by H-NMR, Mass & Ms/Ms,

HPLC & IR.

* Degradation studies

* Responding queries related to DRA

* Maintaining stability data of all impurities.

* Report making.

Technical Expertise:

. Expertise in Multi-Step Organic Synthesis.

. Expertise in the Literature Search through Manual &

Internet.

. Expertise in the High Pressure & Dry Reactions.

Projects Handled: (Projects as per alphabetical order).

I worked on impurities of projects like:-

Allopurinol,Alvimopan,Ammoxicillin

trihydrate,Artemether,Atazanavir,Atorvastatin,Benazepril,Cabergoline,Cefdini

r,Cetirizine,Cilastatin,Cilazapril,Clopidogrel,Entacapone,Eslicarbazepine,Fe

xofinadine,Imipenem,Itraconazole,Loperamide,Loratadine,Lumifantrine,Midazola

m,Milnacipran,Mycophenolate,Nelfinavir,Orlistat,,Quinapril,Rispiridone,Sertr

aline,Telbivudine,Zidovudine

Job Responsibilities in Noble Drugs Ltd.

Raw material analysis, in process sample analysis and finished product

analysis on HPLC

Analysis of all Formulation products, tablet, capsules and liquids along

with documentation Following Good Laboratory Practices

Instruments Handled: HPLC (Agilent, Waters)

UV/VIS Spectrophotometer, Karl fisher titrator, Potentiometer,

Refractometer, Viscometer, Melting point apparatus. Auto Dissolution

tester, and Auto Titration Apparatus, Hardness Tester, Friability Test

Apparatus, Tapped Density Apparatus, Disintegration Test Apparatus etc.

Educational Qualification:

. Master of Science in Organic Chemistry, (May 2002)

. B Sc. From Pune University, (April 2000)

. HSC from Nasik Board, (Mar' 1997)

. SSC from Pune Board, (Mar'1995)

Achievements:

. Qualified Graduate Aptitude Test for Engineering

(GATE): 2003 (87.23 Percentile).

. Qualified WIPO,s DL101 distance learning course with

first class

. in Fexofinadine for the novel work in characterization

of unknown impurities in the API

. Completed Advance Post Graduate Diploma in Regulatory

Affairs ( API + Formulation ) in Institute of

Pharmaceutical Management

Computer Skills:

. ACD labs, MDL cross fire, Microsoft Office, Internet

explorer, etc.

. Diploma course in Computer programming(six month )

Hobbies:

. Traveling.

Strengths:

A high level of commitment towards work.

Task oriented and able to work under defined work

parameters.

Adaptable to changing work culture and environment.

Great fluency in spoken English.

Believe in following high standard of personal

and work ethics

Personal Information:

Father's Name : Mr. Ashok D Chavan.

Mother's Name : Mrs. Surekha Ashok Chavan.

Permanent Address : 8, Chittapawan Row Housing society,

Behind Church, Indira Nagar, Nashik,

Maharashtra.

Pin-422009

Mob. No. 098********

Date of Birth : 1st Feb 1980.

Nationality : Indian

Marital Status : Married.

Sex : Male

Languages Known : English, Hindi, and Marathi.

References:

* Dr .G. M. Nigal,

Reader of Chemistry,

P.V.P. Collage, Pravaranagar,

Pune University, (Maharashtra)

Tel:-024**-******

(Datta A Chavan.)

Date:

Place: Nashik.

Contact this candidate