Quality Control Maintenance

ALEXANDRA DRAGHICI

**** ******* **., ********* *****, MI, 48309

Phone; 248-***-****

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

OBJECTIVE

I am a professional looking for challenging opportunity within the pharmaceutical/chemical industry

where I can utilize my skills and experience to contribute to an organization’s growth, success and

profitability.

HIGHLIGHTS OF QUALIFICATION

• Experience in Analytical Laboratory, Quality Control, R&D and pharmaceutical

manufacturing;

• Practical experience using instrumental analytical methods, HPLC, TLC, GC (FID, TCD,

TPGC), UV, IR, calibration and maintenance;

• In-depth knowledge of classical (wet) Analytical Chemistry procedures (specific gravity,

titration, Karl-Fisher, pH-meter, colorimetric, dissolution, stability, viscosity);

• Thorough understanding of pharmaceutical GLP and GMP requirements, good knowledge of

MS Office programs, Word, Word-Perfect, Excel, Chem Station, Empower, Millennium, search

in chemical databases;

• Experience in research to develop new products and processes, new analytical methods for

organic compounds as biological active compounds (synthesis, extraction, purification and

distillation);

• Experience in synthesis and purification of target compounds from milligram to kilogram scale

using modern organic chemistry technique;

• Experience with applications for inventions, industrial and intellectual property.

PROFESSIONAL EXPERIENCE

12/2006 -03/2009- Bureau Veritas North America, Inc- Novi Laboratories

ANALITICAL CHEMIST- HPLC Department

Responsible to prepare samples and standards to perform HPLC (Waters- Empower,

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Millennium) analysis for pharmaceutical compounds;

Document, interpret results and chromatograms, and report test results within the scheduled

•

time interval according to appropriate SOPs, analytical procedures and regulatory requirements;

Developed, validated and document new methods of analysis applicable for new compounds;

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Performed general laboratory duties such as: equipment maintenance, troubleshooting and

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instrument calibration, ordering lab supplies;

Performed laboratory duties and other assigned tasks to meet unscheduled work demands

•

03/ 2005- 09/ 2005 Germiphene Corporation, QC Department, Brantford, Canada

QC ANALYTICAL CHEMIST

• Responsible for sampling and physical/chemical testing to verify the quality of raw materials,

intermediates and final products with instrumental and chemical techniques (as per EP, USP, BP and

in-house).

• Prepare samples, perform and interpreted spectra and chromatograms for TOC Schimatzu, HP,

Agilent and Varian GCs (FID, TCD), Waters, Varian and Agilent HPLCs according to established

SOPs and QC/QA protocols, select and perform analytical methods. Maintain instrument systems in

good working order.

• Evaluated, interpreted data and completed written reports to indicate deviations from existing

standards.

• Evaluated, developed and validate new methods and procedures in the use of equipment and

procedures for analyzing samples.

• Operated and maintained laboratory equipment and apparatus, prepared solutions of liquid,

reagents, and sample formulations.

09/1988-03/ 2003 National Institute for Chemical-Pharmaceutical Research and Development

(ICCF), Research of Drug Synthesis and Analysis –Bucharest, Romania

R&D CHEMIST

• Conducted research to develop new products biological active and processes;

• Conducted synthesis and purification of target compounds from milligram to kilogram scale

using modern organic chemistry and transfer the processes in pharmaceutical plants;

• Synthetic processes solutions from laboratory to pilot scale, isolation and identification by

analytical techniques (chromatographic, spectroscopic);

• Contributed as part of a team of science professionals to meet business objectives;

• Coordinated, organized, scheduled and supervised chemists, technicians and technologists of

the drug synthesis team;

• Wrote Project Updates and R&D Reports;

• Perform analytical tests and interpreted chromatograms for GC (FID, TCD), and HPLC;

• Performed all classical (wet) Analytical Chemistry procedures as specific gravity, titration,

Karl-Fisher, pH-meter, colorimetric, heavy metals, dissolution, stability, viscosity;

• Evaluated, developed and validate new methods and procedures in the use of equipment and

procedures for analyzing drug samples.

EDUCATION

Master’s Degree in Chemical Engineering- Educational Credentials Evaluated by ECE-

Milwaukee, WI

“Polytechnic Institute of Bucharest”, Romania, 1982-1988

Faculty of Chemical Technology - Major in Organic Chemistry

TRAINING AND PROFESSIONAL DEVELOPMENT

• Seneca College - Faculty of Continuing Education, Toronto, Canada, 2004

Lab Assay Methods, Method Development, Gas Chromatography and HPLC

• International Academy-European Patent Office – Berlin, Certificate 2001

Search in databases and substantive examination for patents at the EPO

• World Intellectual Property Organization-WIPO Worldwide Academy, Certificate 2001

OTHER LANGUAGES: Spanish, Romanian

REFERENCES: Available upon request

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