Summary
Overview
Work History
Education
Skills
Work Exposure
Software Exposure
Instrument Exposure
Timeline
Generic

Sharmila R

Chennai

Summary

Insightful professional with over 10 years of experience in pharmaceutical industry, seeking challenging role within progressive organization that fosters personal and professional growth through determination, dedication, and strategic effort.

Overview

10
10
years of professional experience

Work History

Senior QA Associate

Novitium Labs Pvt Ltd
Chennai
01.2023 - Current
  • Reviewed analytical documents, OOT, OOS, and deviations to ensure compliance with standards.
  • Managed batch release processes, maintaining high product quality and safety standards.

Analyst-Quality control

Par formulation Ltd
Chennai
07.2018 - 12.2022
  • Conducted stability studies for formulation products to ensure compliance with regulatory standards.
  • Analyzed samples to evaluate product performance and longevity.
  • Maintained facility compliance with USFDA and cGMP regulations.
  • Oversaw documentation processes for stability testing and sample analysis.

Junior Executive- Quality control

Actavis Pharma Development Centre
09.2015 - 07.2018
  • Conducted responsible stability studies for formulation products.
  • Ensured compliance with industry standards throughout stability evaluations.

Education

M.SC Chemistry -

DG VAISHANAV COLLEGE
Chennai
09-2015

Skills

  • Quick learning ability
  • Decision making
  • Strategic planning
  • Multitasking
  • Team collaboration
  • Effective communication
  • Team leadership
  • Deadline management

Work Exposure

  • Review of analytical documents and compilation
  • Handling of laboratory incidents and deviations
  • Preparation of the worksheet, along with stability management, SOP preparation, and stability protocols preparation
  • Analyzing routine testing of stability samples in accordance with standard operating procedures (SOP) for product release
  • Routine analysis of dissolution, assay, and related substances for finished products and stability samples
  • Wet analysis, such as moisture content, loss on drying, viscosity, water content, and IR
  • Hands-on experience with HPLC analysis and handling UPLC, polarimeter
  • Performed analytical method validation and method transfer as per protocol and report generation
  • Preparation of standard testing procedure, compilation of stability documents, and preparation of summary report

Software Exposure

  • LIMS version 5, 6
  • STARLIMS version 11

Instrument Exposure

  • High Performance Liquid Chromatography
  • Waters Alliance e2695
  • Agilent 1260 infinity series (Software: Empower 3, with custom field)
  • Fourier Transform-Infrared spectroscopy
  • Perkin Elmer Spectrum two with Spectrum ES software
  • Shimadzu IRAFFINITY1 with LabSolutions software
  • UV SPECTROPHOTOMETER
  • Shimadzu 1900
  • 160A Agilent with LabSolutions software
  • Karl Fischer Titrator
  • Metrohm 809 Titrando (2.4 & 2.5 tiamo software)
  • Dissolution Apparatus (Electro Lab, Distek and Hanson dissolution Tester)
  • Polarimeter: SOR-Rudolph (Autopol 6)

Timeline

Senior QA Associate

Novitium Labs Pvt Ltd
01.2023 - Current

Analyst-Quality control

Par formulation Ltd
07.2018 - 12.2022

Junior Executive- Quality control

Actavis Pharma Development Centre
09.2015 - 07.2018

M.SC Chemistry -

DG VAISHANAV COLLEGE

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Sharmila R