Development Quality Control
Resume:
CURRICULUM VITAE
Selvaraja Elumalai
E-mail id: ***********@**********.***
****,********* *******,******-*****
Cell no: +1-732-***-****
OBJECTIVE:-
To seek a challenging career that enables me to utilize my current
skill set towards helping my organization remain competitive and
innovative. At the same time, to choose opportunities that helps me sharpen
and improve upon my talents.
EXPERIENCE:-
Current Job;
Designation: Senior Scientist-
Organization: Medcore Pharma LLC,NJ,USA.
Years: Oct2012
Responsibilities:
> In-charge for the Quality and Analytical division for the project
delivery.
> Handling a development team with 12 Research associates for Solid
dosage forms
> Co-ordination with Vendor for the DMF related issues in
Analytical methods and Specifications
> In-Charge for the cGMP and GLP activities.
> Reviewing analytical method validation and development documents
like Assay, Related Compounds, Dissolution and other analysis
> Reviewing STP and Sop's for analytical department related products
and instruments.
Designation: Scientist-1
Organization: Aurobindo Pharma Ltd, Hyderabad,India.
Years: Jul-2010 to Oct2012
Responsibilities:
> In-charge for the Analytical method development division for the
project delivery.
> Handling a development team with 8 Research associates for Liquid
dosage forms, Oral Contraceptives and Ophthalmic
> Co-ordination with Vendor for the DMF related issues in
Analytical methods and Specifications
> Development for Assay, Bio assay (Like Heparin and Enoxaparin
molecules) and Related Substance for parental dosage form,
ophthalmic solutions and Oral contraceptives.
> In-Charge for the cGMP and GLP activities.
> Coordinating with third party vendor for method verification of
analytical methods.
> Leading tech transfer team for Solid oral dosage forms and API.
> Reviewing analytical method validation and development documents
like Assay, Related Compounds, Dissolution and other analysis
> Reviewing STP and Sop's for analytical department related products
and instruments.
> Preparation of protocols and conducting validations for products
intended for Generic market.
> Ensuring lab compliance as per regulatory requirement.
> Co-coordinating with purchase division to negotiate the price for
columns and impurities
> Crucially worked for cost reduction activities.
> Co-coordinating with project management team about the project
updates as per the current market strategy.
Designation: Deputy Manager
Organization: Genovo Development Services Ltd,
Bangalore,India.
Years: Nov 2009 to Jul 2010
Responsibilities:
> In-charge for Pilot plant activities.
> Handling a team of 14 analyst for the Solid dosage forms .Includes
analytical Development,Validation and final project stability
activities
> Preparation of Specifications and Standard testing procedure for
the pilot plants.
> Preparation of documents for Vendor qualification as per the DMF
requirements.
> Preparation and execution of Analytical method verification and
method validation for API.
> Preparation and execution for the method transfer activities .(
Inter and Intra lab)
> Preparation and execution Method Equivalency as per USP
requirements.
Designation: Senior Scientist
Organization: Actavis Pharma, Chennai,India.
Years: Aug 2007 to Nov2009
Responsibilities:
> Leading development team with 5 scientist and additional
responsible for support team of 4 scientist.
> In-charge for the Lab establishment as per the USFDA facility
requirements.
> In-Charge for the System Security activities of Empower server and
systems.
> Co-ordination with Vendor for the DMF related issues in
Analytical methods and Specifications
> Coordinating with third party vendor for method verification of
analytical methods.
> Leading tech transfer team for Solid oral dosage forms and API.
> Reviewing analytical method validation and development documents
like Assay, Related Compounds, Dissolution and other analysis
> Reviewing STP and Sop's for analytical department related products
and instruments.
> Preparation of protocols and conducting validations for products
intended for Generic market.
> Ensuring lab compliance as per regulatory requirement.
> Preparation of Specifications and Standard testing procedure and
reviewing DMF documents.
> Preparation of annual reports for the lab activities.(Coasting
activity).
> In charge for the Optimization batch activities.
> Preparation of Instrument IQ, OQ, PQ protocols and execution of
the protocols for HPLC, DSC, Dissolution, Balance.
> Leading the team with eight peoples and execution of RS, Assay,
Dissolution method validation and development.
> Performing Computer System Validation for Empower Client.
> Preparation of SOP related to analytical instruments as per the
Lab requirements
Designation: Junior Manager
Organization: Dr.Reddy's Laboratories (Generics Division), Hyderabad,India.
Years: 2005 to 2007
Responsibilities:
> Method Development:
Development of Analytical Methods for Solid dosages, Injections,
Ophthalmic solutions as per USFDA & ICH guidelines for Related
Substances, Assay, Dissolution, CU, UOD. Infusion Study, Stability
studies of Premix Solutions.
> Method Validation:
Able to execute independently validation protocols for validation of
analytical methods for routine quality control analysis as per USFDA
& ICH guidelines for all product parameters.
Preparation of summary reports for Dissolution, Related Substance,
Assay, CU, Residual solvents, Residue analysis & UOD method
validation protocols and Infusion study reports which later become
part in ANDA submission.
> Calibrations:
Carried out calibrations for different HPLC'S and Dissolution
Systems, Analytical Balances, Differential Scanning Colorimeter (DSC-
823).
> Actively participating in product development strategies ensuring
the timely completion of projects.
> Exploring latest analytical developments in the pharmaceutical
industry.
> Literature survey for project, guidelines and updating the current
developments in analytical field.
> Ensuring the Analytical Method Development and method validation
of Projects from Commercial lab to US lab For Paranteral dosage
forms.
> Reference & Working Standards:
Analysis of working standards for drug products.
Supporting in procurement of calibrations
reference standards
Designation: Executive
Organization: Strides ArcoLabs Pvt. Ltd, Bangalore,India.
Years: 2004 to 2005
Responsibilities:
> Method Development:
Development of Analytical Methods for Solid dosages, Injections, as
per USFDA & ICH guidelines for Related Substances, Assay,
Dissolution, CU, UOD.
> Method Validation:
Able to execute independently validation protocols for validation of
analytical methods for routine quality control analysis as per USFDA
& ICH guidelines for all product parameters.
Preparation of summary reports for Dissolution, Related Substance,
Assay, CU, Residual solvents, Residue analysis & UOD method
validation protocols and Infusion study reports which later become
part in ANDA submission.
> Reviewing analytical method validation and development documents
like Assay, Related Compounds, Dissolution and other analysis
Designation: Executive
Organization: Cavin Kare Pvt. Ltd, Pondicherry,India.
Years: 2002 to 2003
Responsibilities:
> Reviewing analytical method and development documents like Assay
activities.
> Reviewing STP and Sop's for analytical department related products
and instruments.
> Preparation of protocols and conducting validations for products
intended for Generic market.
> Ensuring lab compliance as per regulatory requirement.
> Working with QA department for the analytical related issues.
INSTRUMENTAL KNOWLEDGE
Having knowledge in handling, Calibration & troubleshooting of
> High Performance Liquid Chromatography DAD / PDA (Waters, Agilent &
Shimadzu)
> Dissolution apparatus (I,II,III,IV) (Lab India, Electrolab, Vankel )
> Differential Scanning Colorimeter (Shimadzu)
> Atomic Absorption Spectroscopy
> Particle size analyzer (Malvern )
> FT-IR Spectrophotometer (Shimadzu & Perkin Elmer)
> UV Spectrophotometer (Varian & Shimadzu)
> Auto titrator (Metrohm)
> Karl Fischer Auto titrator (Metrohm)
> Polarimeter (Jasco)
> Melting point apparatus (Mettler Toledo)
Achievements:-
> Letter of Appreciation from Vice President R&D of Dr. Reddy's Labs for
solving the dissolution problem in FLUOXETINE DR CAPSULES by USP III
apparatus and hence helping in USFDA filing of the product.
> Letter of Appreciation President R&D of Dr. Reddy's Labs for method
development of GRANISETRON HCL and IRINOTECAN HCL Injections within a
short period of time and hence helping in USFDA filing.
.
ACADEMIC QUALIFICATION:-
> MSc.,Physical Chemistry, with Ist class, (University of Madras, Chennai-
25.)
BSc.Chemistry(First Class) St.Joseph's
Collage of Arts & Science Cuddalore, Madras
University.
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