Training Testing

SUMMARY

A Scientific Professional with strong experience in the Pharmaceutical

industry. Current expertise involves compliance and documentation audit of

Finished products, Raw materials, In-process samples, Stability samples,

Validation reports, Standardization and Calibration reports, knowledge of

GLP and cGMPs. Includes analytical testing for pharmaceuticals products.

EXPERIENCE

Teva / Ivax / Zenith Pharmaceuticals Inc., Northvale, NJ 09/1993-

04/2008

1 QC Chemist & Auditor / R & D Auditor/ Stability Chemist

2

> Responsible for Analytical Data review of Laboratory test reports

for finished products, intermediate, raw materials, in-house

standards, validation reports, stability data, cleaning validation

reports and instruments calibration data

> Responsible for administration of USP, NIST and In-house reference

standards.

> Managed process for logging incoming samples for testing &

distributing to analysts

> Responsible for issuing worksheets for testing and complied

worksheets for review process

> Ordered USP/NIST reference standards, Columns, Volumetric Solutions,

Chemicals & Reagents & managed inventory.

> Ensures compliance with SOPs, cGMPs and GLPs.

> Work closely with all levels of personnel within the scientific

environment.

> Performed method validation, cleaning validation, stability analysis

of solid/semi-solid/liquid and parenteral dosage forms following USP,

company's approved test procedures and SOP's by HPLC, GC, TLC, UV, IR, or wet chemistry.

> Expert in Dissolution testing in compliance with cGMP, GLP and set

guidelines of the company.

> Performed standardization, water content determination by Karl-Fisher

and identification tests by FTIR.

> Calibration of HPLC, dissolution units, balance, pH meter and

Thermometers.

> Responsible for cGMP and GLP compliance issues with strong knowledge

of its documentation.

> Auditing logbooks of he laboratory instruments for its compliance.

2

3 Time Cap Lab, Farming Dale, NY

Analytical Chemist/QC 10/1992 - 09/1993

> A wide experience of performing wet chemistry analysis including

extraction, purification, LOD/LOQ, Heavy Metals determination, etc.

> Preparation and standardization of volumetric solutions for testing.

> Analysis of raw materials, drug products including assay, impurity,

content uniformity and dissolution using various analytical

techniques.

4 Hampton University, Hampton, VA

11/1990-09/1992

Research Associate/Biochemical Lab

> Estimating vitamin E level in oyster.

> Developing technique, teaching students laboratory procedures,

keeping records, making assignments, etc.

Par Pharmaceuticals, Spring Valley, NY

Analytical Chemist/QC Stability 01/1988 - 06/1990

> Routine stability analysis of drug products using various

analytical techniques in accordance with USP methods or In-house

methodologies in compliance with set regulations of the company.

INSTRUMENTATION

HPLC (Waters Alliance, HP 1050 and 1100, Perkin Elmer, Spectra-Physics),

GC (PE, HP), Dissolution Apparatus

(Vankel, Distek), UV-Vis spectrophotometer (PE, HP), Karl-Fischer

(Brinkmann), FTIR (Nicolet), Melting Point apparatus, Brookfield

Viscometer,

JOB RELATED TRAINING

> HP Chemstation, Turbochrom, Millennium32, UV-VIS Chemstation and PE

Nelson LIMS

> cGMP, GLP, safety and OSHA's training

> Method development and validation course

> Computer software MS Word, Excel, Spreadsheets, Power Point, Lotus

Notes

EDUCATION

LasComp Insitute - Hackensack, NJ

Microsoft Office 2003

2 MS University - India

3 B.S. - Chemistry

Minor: Physics and Mathematics

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