Quality Control Manager
Resume:
C u r r iculum Vitae
Harshad Manohar Naik
M.Sc. ( Chemistry )
*** *************, **** ******** ****,
P rabhadevi, Mumbai-400025
M obile No.982*******
E mail I d -*************@*****.***
Objective
To Built a career which enables to maximize my potential talent and inner potential and contribute
my wellbeing towards development of organization. Strive to enhance the effectiveness and
efficacy of all function through dedication and commitment in my entire endeavor in a dynamic
organization this would also facilitate the continual learning.
Summary
About 15 years of experience( from Aug.1998 till date ) including 4 years in Quality Control. Well
versed in preparation,review, submission, registration document / Dossier in India,International
Market, ROW countries, in CTD/A-CTD format as per country specific requirement, key
knowledge as follows
Preparation for pharmaceutical dossier for India and International market.
Registration of pharmaceutical product in Kenya, Uganda, Tanzania, Brazil.
Good knowledge of U.S. and Europe e-CTD preparation and submission.
Well versed with CTD/ e CTD and A-CTD format.
Having a good knowledge with CDSCO submission.
P rofessional Experience :
■ Worked in :- M/S Manbro Pharma Pvt. Ltd, M IDC,
Dombivali
Work Period : - Since Dec 2007 t ill Date.
Designation :- as Manager Regulatory Affair
Type of drug manufacturing :-Tablet, L iquid, Capsule, Powder, Cream.
■ Worked in :-M/S T hemis Lab LTD, Thane
Work Period : - since Aug 2004 to Nov 2007
D esignation :- as Regulatory Affair executive
Type of drug manufacturing: - Tablet, Capsule.
■ Worked in :- Aviat Chemical Pvt. Ltd ., Juinagar
Work Period : - Since June 2002 to July 2004.
Designation : - R.A. Executive.
Type of drug manufacturing :- A.P.I, Liquid,
■ Worked in :- M/S Rusi Remedies Pvt. Ltd ., Vasai
Work Period : - Since Aug 1998 to May 2002.
Designation : - Q.C. Officer.
Type of drug manufacturing :- A.P.I, Liquid, Tablet, Capsule, Injection.
Computer Skills
MS-word, Excel.
S trengths
Ability to work under pressure and without supervision.
Willingness to accepts additional responsibility
Always interact with colleagues for sharing knowledge and information.
Proactive and quick response.
Eager to learn new things to enhance knowledge.
Possess strong human relationship and effective communicate
A dditional I nformation
F.D.A. approved in chemical & Instrumentation & M icrobiology ( Maharashtra )
D ate of Birth : 2nd November 1977
Sex : M ale.
M a r tial Status : M ar r ied.
N ationality : I ndian.
L anguage Known : E nglish, Hindi, Marathi.
E ducational Qualification
M.Sc ( Chemistry ) from Vinayaka Mission University, Tamilnadu, with First class in 2011.
B.Sc. (Chemistry) from Kirti college of Art, Science and Commerce, Mumbai, Maharastra
with First class in 1998.
12th with first class from Kirti college of Art, Science and Commerce, Mumbai, Maharastra
in 1995.
10th with First Class from Mumbai, Maharastra, in 1993
Job Description
Preparation and review of dossier as per current prescribed guideline of the respective
regulatory authority.
Registration of pharmaceutical product in Kenya, Tanzania, Uganda, Brazil.
Ensuring that the documents are compiling to international submission.
Well versed with Indian regulatory authority for manufacturing license, Sale license, product
registration, COPP, Free sale certificate, No conviction certificate, performance certificate etc.
Preparation of document for grant of clinical trial in India ( CDSCO Submission)
Preparation of pharmacology, preclinical data, clinical data based upon published literature.
Preparation and review of SmPC, Package insert, labeling instruction.
Preparation and submission document for MAA (U.K.) and ANDA (U.S.)
Preparation and submission of C.M.C. changes ( Type IA,IB,II variation for U.K. ) and ( A.R.,
CBE-0, CBE-30, PAS for U.S.)
DECLARATION
I hereby declare that the information given is t rue to the best of my knowledge
.
P LACE
DATE
( Harshad M. Naik)
Contact this candidate