Mr. DATTA ASHOK CHAVAN.
behind church, near Wadala-
pathardi road, Indira nagar,
Nasik, Maharashtra, pin-
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
* 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
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
* 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
* Synthesis/Purification of desired impurities.
* Synthesis of In-house impurities & pharmacopoeial impurities. (EP &
* Synthesis of metabolites for Bio-Equivalence study (Generics).
* Generating the material for toxicity of impurities.
* Purification of the different impurities by using columns
* 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.
. Expertise in Multi-Step Organic Synthesis.
. Expertise in the Literature Search through Manual &
. Expertise in the High Pressure & Dry Reactions.
Projects Handled: (Projects as per alphabetical order).
I worked on impurities of projects like:-
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.
. 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)
. Qualified Graduate Aptitude Test for Engineering
(GATE): 2003 (87.23 Percentile).
. Qualified WIPO,s DL101 distance learning course with
. 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
. ACD labs, MDL cross fire, Microsoft Office, Internet
. Diploma course in Computer programming(six month )
A high level of commitment towards work.
Task oriented and able to work under defined work
Adaptable to changing work culture and environment.
Great fluency in spoken English.
Believe in following high standard of personal
and work ethics
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,
Mob. No. 098********
Date of Birth : 1st Feb 1980.
Nationality : Indian
Marital Status : Married.
Sex : Male
Languages Known : English, Hindi, and Marathi.
* Dr .G. M. Nigal,
Reader of Chemistry,
P.V.P. Collage, Pravaranagar,
Pune University, (Maharashtra)
(Datta A Chavan.)