Quality Assurance Control

Tejaswi koduri,

**** ***** ****, *** **** Mob: 603-***-****

Camarillo, CA, 93012 *******.******@*****.***

Professional Summary

• Extensive experience in Analytical method development and validation by RP-HPLC, LC-MS/MS techniques.

• Solid experience in qualitative and quantitative assessment of products/compounds using techniques such as HPLC, LC/MS, FT-IR and UV-VIS.

•Very good experience in analytical instrumentation handling, wet chemistry and microbiological techniques.

• Broad knowledge on GMP, GLP, GCP, ICH guidelines, SOP's, EPA standardized method analysis of environmental samples.

•Familiar with dissolution & disintegration testing and quality control of pharmaceutical compounds.

Educational Qualification

•Masters in Pharmaceutical Analysis & Quality Assurance- Andhra University, India in 2011 with 8.9 SGPA

•Bachelors in Pharmacy - Acharya Nagarjuna University, India in 2009 with 87%.

Work Experience

Assistant Professor, CHIPS, India (March 2012-May 2014)

•Teach undergraduate, graduate courses & conduct practical sessions related to Pharmaceutical Analysis & Quality Assurance .

•Participate in course design, development, implementation and evaluation to provide appropriate learning experiences for students.

•Demonstrate competence and leadership within a defined area of pharmacy practice.

•Participate in research or practice activities according to preparation and expertise.

•Maintain academic excellence in education, practice and /or research through participation in continuing education programs.

•Participate in the scholarship process, such as presenting at State, National or International conferences.

•Perform the role of Academic advisor to students.

Research Intern, Bio-Analytical R&D, Natco Research Centre, India (Jan 2011- sept 2011)

•Completed a research project titled as “Bio analytical Method Development& validation for the quantitation of Zolmitriptan present in Human Plasma using LC-MS/MS”.

Developed a simple, accurate, precise analytical method for the assay of Anti- Migraine drug Zolmitriptan using Rizatriptan as an Internal standard by LC- MS/MS. Simple, cost effective solvent extraction procedures are used to separate Zolmitriptan from blood & plasma samples. This method is properly validated as per ICH guidelines and the results are within specifications.

•Analyzed the compounds Zolmitriptan & Rizatriptan by HPLC, UV-Vis for checking the impurities and the percentage purity after stress degradation studies.

•Mainly worked on Analytical method development & validation of newly developed anti-cancer drugs

•Perform bio- analytical assay methods for the quantitative estimation of drugs in biological samples.

•Perform daily calibration for weight balance, pH meter and Karl Fisher Titration; water analysis using Karl Fisher Titration; and analytical analysis of Stability samples, Process Validation samples and finished drug product samples using internal methods following SOPs, cGMP and FDA regulations.

•Evaluate the raw material and product quality by performing various procedures in wet chemistry and HPLC analysis on in-process, finished goods, raw materials, and stability products.

•Perform qualitative & quantitative estimation of Raw materials, Intermediates and finished products as per SOP’S.

QA Intern, Dr. Reddy’s Laboratories, FTO-III, Generics, India (Oct 2010-Dec 2010)

•Well trained on cGMP, GLP, ICH guidelines as a part of course curriculum.

•Monitor In-process quality controls and design Statistical quality control (SQC) charts & monitoring the process variables.

•Instrumentation or equipment setup, maintenance, trouble shooting, calibration and validation.

•Update SOP’s, reviewing analytical reports, and analyst notebooks.

•Perform equipment qualifications & validation as per the guidelines.

•Develop validation protocols, summary reports for validating QC laboratory equipment.

•Review standard operating procedures (sop’s) for various processes & equipment’s.

•Perform various quality control tests including friability, dissolution/dispersion tests and disintegration tests on tablets and maintained detailed records of the results.

•Execute raw material receipt, inspection & sampling including completion of GMP documentation to support raw material disposition.

•Investigate, review & approve non-conformance investigation, manage corrective action plans to prevent issue reoccurrence.

Publications

•Method development & validation for simultaneous estimation of Olmesartan Medoxomil & Hydrochlorothiazide by RP-HPLC, Oriental Journal of Chemistry, Vol 30 (1), pg. 195-201, (2013).

•Analytical method development & validation for simultaneous estimation of Enalapril Maleate & Hydrochlorothiazide by RP-HPLC, Der Pharma Chemica, Vol 6 (1), pg. 217-223, (2013).

•Validation of a novel RP-HLC method for simultaneous estimation of Amlodipine Besylate & Nebivolol Hydrochloride in Bulk & Pharmaceutical Dosage forms, International Journal of Pharmaceutical Sciences & Research, Vol 5 (8), pg. 3273-3278, (2014).

•A Validated UV Spectrophotometric method for simultaneous estimation of Hydrochlorothiazide, Amlodipine Besylate & Telmisartan in Bulk & combined tablet Dosage Forms, Der Pharmacia Lettre, Vol 6 (4), pg. 449-455, (2014).

•Development & Validation of RP-HLC method for simultaneous estimation of Hydrochlorothiazide, Amlodipine Besylate & Telmisartan in Bulk & Pharmaceutical Dosage Forms, Oriental journal of Chemistry, Vol 30 (4), Pg 1815-1822, (2014).

Achievements

•Stood university second during my Bachelors and got medal form the Acharya Nagarjuna University in 2009.

•GATE qualified with 89.66 percentile and 2484 rank in the year 2009.

•Participated in a 2 day National conference on “New dimensions in Pharmaceutical sciences” & successfully presented a research paper on 12th, 13th March 2010.

•Participated in AICTE sponsored national seminar on Pharmaceutical Analysis o 24th, 25th April 2010

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