Summary
Overview
Work History
Education
Skills
Accomplishments
Projects
Personal information
Linguistic Ability
Disclaimer
Timeline
Generic

NANCY CHAUDHARY

Bangalore

Summary

Highly experienced in Senior executive roles with a focus on quality assurance. Strong background in developing and implementing robust quality control processes, enhancing product reliability, and maintaining compliance with industry standards. Demonstrated strengths include leadership, strategic planning, problem-solving skills, and ability to drive continuous improvement initiatives.

Overview

8
8
years of professional experience

Work History

Senior Executive (Quality Assurance)

Biocon Biologics Limited
Bangalore
10.2023 - Current
  • QMS Review & Approval (CAPA, Change Control, Risk Assessment, Gap Assessment)
  • Market Complaint Investigation
  • Audit compliance and management
  • Trend report preparation for Quality Performance indicators
  • Site Board Review Meeting Management.
  • Cpordination with Cross functional teams for Ontime closure of Quality events & Audit response.

Executive (Quality Control)

Biocon Biologics Limited
Bangalore
10.2019 - 10.2023
  • Analytical testing of biosimilar drugs (HPLC, protein concentration, pH, osmolality, CCIT).
  • Method Transfer & Method Validation
  • HPLC Calibration
  • Management of Stability Studies
  • Qualification & Management of Reference Standards
  • OOS & Lab Incident Handling & Hypothesis

Executive (Quality Control)

Intas Pharmaceuticals
Ahmedabad
07.2017 - 09.2019
  • Stability Inception & withdrawal of samples.
  • Batch data review and compilation.
  • Analytical Testing of Drugs (SDS-PAGE electrophoresis, IEF, HCP, HCD)
  • OOS investigation closure

Education

M. Tech - Biotechnology

VIT University (Vellore Institue of Technology )
Vellore
05-2017

B. Tech - Biotechnology

Banasthali University
Jaipur, India
04-2015

Skills

  • Quality management system
  • Audit compliance and management (USFDA, EMA, ANVISA, CDSCO, ISO)
  • Market Complaint Investigation for Medical Devices
  • Regulatory compliance (ICH Guidelines , ISO 13485 )
  • Analytical testing of biosimilars
  • Software expertise (Labware LIMS, Track wise, LabSolutions, Empower)
  • 5S implementation in the lab
  • 21 CFR Part 11
  • Method validation
  • Method transfer
  • HPLC Calibration
  • Management of stability studies

Accomplishments

  • Awarded the Achiever Award at Biocon Biologics, 2024
  • Received merit Scholarship in VIT University, 2016
  • Diploma in German Language (2012-2014)

Projects

  • Effect of antiepileptic drug on multidrug resistance protein 2 (MRP2) expression in different mammalian cell lines, 6 months, CSIR-IGIB, New Delhi
  • Characterization and strain improvement of microbes of commercial significance, 10 months, Anthem Biosciences, Bangalore
  • Adsorption of dyes in fixed bed reactor systems using coconut fibers, 3 months, VIT University

Personal information

  • Father's Name: Surendra Kumar
  • Date of Birth: 09/03/93
  • Gender: Female
  • Nationality: Indian
  • Marital Status: Married

Linguistic Ability

  • English
  • Hindi
  • German

Disclaimer

I hereby declare that all information provided in this resume is true and correct to the best of my knowledge and belief.

Timeline

Senior Executive (Quality Assurance)

Biocon Biologics Limited
10.2023 - Current

Executive (Quality Control)

Biocon Biologics Limited
10.2019 - 10.2023

Executive (Quality Control)

Intas Pharmaceuticals
07.2017 - 09.2019

M. Tech - Biotechnology

VIT University (Vellore Institue of Technology )

B. Tech - Biotechnology

Banasthali University

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