Quality Assurance Data

AMITA PATEL

Email: ************@*****.*** Hoffman Estates, IL-60169 Cell: 331-***-****

OVERVIEW: To apply my academic knowledge practically and to utilize my technical skills and abilities in a challenging way that offers advancement and professional growth to my career. TECHNICAL SKILLS: Operation of analytical instruments

HPLC: LC 10AT–UV 10AT (Shimadzu, Japan) FT-IR (Bruker, alpha)

HPLC with PDA detector and RI detector Centrifuge

UV-Spectrophotometer: UV-1700;UV–1800(Shimadzu, Japan) TLC

Spectrofluorometer: RF-5301PC (Shimadzu, Japan) pH meter, Density meter

Dissolution Test Apparatus Analytical balance

Software Skill: Clarity, LC Solution, Lab Solution (HPLC), RFPC (Spectrofluorometer), UV-Probe (UV-Vis Spectrometer), MS- Office.

Standardization and calibration of the lab equipment. EXPERIENCE: Unique Pharmaceuticals Laboratories May 2015 - Feb 2017

(A Division of J.B. Chemicals & Pharmaceuticals Ltd.), India QC Analyst / Trainee QC executive

Analyzed day to day sample of Stability sample, Process Validation sample, finished product sample, in- process samples and Raw material, allocated by supervisor.

Analyzed In-process, finished product, Raw material and Stability sample on HPLC, UV and IR instrument and chemical analysis as per specification.

Following stability protocol for stability product testing and reporting results.

Perform trend analysis against historical data to evaluate atypical results.

Initiate and complete investigations for OOS/ OOT results.

Performed cleaning validation.

Calibrated laboratory instrument as per SOPs.

Maintained Good Laboratory Practices (GLP).

Login of the sample in LIMS, Analysis as per Analytical work sheet and Entered raw data of an analyzed sample in LIMS.

Maintained column usage records as per part of HPLC documentation.

Maintained system suitability solution records.

Uka Tarsadia University, Maliba Campus, India July 2012 - July 2014 Research Associate

Thesis study: Development and Validation of Spectrofluorometric and HPLC methods for estimation of Zolmitriptan in its pharmaceutical dosage form.

Performed analysis of standard and sample solutions using UV/VIS, FT-IR, HPLC, Spectrofluorometer, Electronic analytical balance & Assay analysis.

Performed chemical solution, mobile phase, diluents & buffer preparation.

Method development and validation by analyzing parameters such as Accuracy, Precision, and Linearity, LOD and LOQ.

EDUCATION: Uka Tarsadia University, Maliba Campus, India July 2012 - Aug 2014 Master of Pharmacy (MS) Major: Quality Assurance

North Maharashtra University, India Aug 2007 - July 2011 Bachelor of Pharmacy (BS)

Contact this candidate