Quality Assurance Control

THU VAN THI TRAN

***** ******* **. ***********, ** 92683

714-***-**** (day); 714-***-**** (evening)

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

OBJECTIVE

• A position in pharmaceutical laboratory such as analytical chemist, QA/QC validation, R&D scientist.

HIGHLIGHTS

• Experience in pharmaceutical field, nutraceutical, and chemical industrial laboratories.

• cGMP, GLP compliance and problem solving.

• Pharmaceutical process, cleaning and analytical method validation.

• Analytical lab improvement and instrument calibration.

• Solid and liquid dosage forms, especially soft gelatin capsule.

• Stability test study, products testing, complaint handling.

• Technical writing: SOPs, validation protocol, testing method.

INDUSTRIAL LABORATORY EXPERIENCE

• Perform qualitative and quantitative analysis for material and finished product as per USP/BP/JP or

internal test methods.

• Operating various analytical instruments: HPLC, GC/FID, UV/Vis spectrometer, Karl-Fisher, titrator,

and other in-process control instruments.

• Familiar with GMP, GLP, 21 CFR111.

EMPLOYMENT HISTORY

Baxco Pharmaceutical Inc, USA- Quality assurance/ Quality control. 2010- 2012

• Prepare document to obtain importing or exporting permits or licenses from CDPH.

• Prepare Vietnamese registration document to get visa for exporting products.

• Responsibility for claiming and checking label including supplement facts, nutrition fact and drug fact

or brochure, flyer, and product catalogue.

• Handlings with product complain and out of specifications.

• Write the SOPs and protocol writing, control and managing.

International Pharmaceutical Companies, Vietnam-Quality assurance/ Quality control 1998-

2009

• Performed task of analytical chemist, quality assurance specialist, or validation specialist

• Quality standards: contributed in the development of quality standards and testing method for

manufacturing process and product.

• Setting up and manage GMP for two international pharmaceutical plants.

EDUCATION

• MS, Chemistry, California Polytechnic University, Pomona, 2014.

• BS, Business Administration, Ho Chi Minh City’s Economic University, Vietnam,2004.

• BS, Pharmaceutical Science, Ho Chi Minh City’s Medicine and Pharmacy University, Vietnam. 1998.

TRAINING

• Biocollaborative life sciences immersion program, University of California San Diego, 2013

• Advanced course on FDA GMP for dietary supplements [21 CFR111], NPA, Anaheim, 2011

• WHO GMP, GSP, GLP training, Drug Administration of Vietnam, 2002, 2004, 2005, 2008

AWARDS

• Valspar chemistry student development scholarship recipient (2014)

• Petro Pharma. Merit scholarship recipient (1998)

RESEARCH EXPERIENCE and INTERESTED

• Polyphenol, flavonoid and derivatives, and natural sunscreen.

• Discover new testing methods and applied it to routine analysis.

REFERENCES

• Available upon request.

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