Summary
Overview
Work History
Education
Skills
Languages
Trainingsattended
Personal Information
Timeline
Generic

Suchita Chourey

Bengaluru

Summary

Experienced QMS Specialist with a proven track record of implementing and maintaining quality management systems to ensure compliance with industry standards and regulations. Skilled in conducting audits, identifying areas for improvement, and developing strategies to enhance quality processes. Strong background in documentation control, training staff on quality procedures, and driving continuous improvement initiatives. A detail-oriented professional with exceptional problem-solving abilities and a commitment to delivering high-quality products and services. Dedicated to fostering a culture of quality excellence within organizations.

Overview

7
7
years of professional experience

Work History

QMS specialist

Syngene international private limited
03.2021 - 10.2023
  • Project planning and coordination.
  • Cross functional collaboration- work closely with internal teams to ensure alignment and timely resolution of project related issues.
  • Monitor and track project progress, ensuring adherence to timelines and identifying potential risks and issues.
  • Maintain accurate and up-to date project documentation, including project plans, meeting notes and client communications.
  • Responsible for preparation and revision of of SOP'S using EDMS software.
  • Initiation of QMS elements i.e, change controls, CAPA, deviations, laboratory incidents, oos, oot, creation and releasing of SOP'S in QMS system.
  • Determining Corrective and Preventive actions and Effectiveness check plans.
  • Handling of LMS, LIMS, ELN, Trackwise and EDMS softwares for routine activities.
  • Creation and preparation of master data/ static data creation in LIMS, ELN and LMS software.
  • Outbound shipment executions.
  • Follow-up of outbound shipments to ensure On-time delivery.
  • Sample management record updation for outsourcing of sample testing.
  • Client interaction for project status.
  • Provide support during client, regulatory and vendor audits.

Scientist

Anthem biosciences Pvt ltd
01.2017 - 03.2021
  • Microbial analysis of source water, R.O water, purified water used in bulk manufacturing of API.
  • Microbial enumeration test for non-sterile finished products according to USP/EP/IP.
  • Environmental monitoring of clean rooms ( Passive and active air sampling and surface monitoring).
  • Growth promotion and inhibitory property tests for both approved and new batches of dehydrated media.
  • Microbial enumeration test for Nitrogen gas and Compressed air.
  • Media preparation and sterilization.
  • Monthly and Annual trend preparations for water analysis and environmental monitoring.
  • Method suitability test.
  • Preparation of SOP'S and method validation protocols.

Education

Master of Science - Biotechnology

VIT University
Vellore, India
01.2016

Bachelor of Science - Biotechnology

Sri Sathya Sai College For Women
Bhopal, India
01.2014

High School Diploma -

ST. Xavier's Senior Secondary Coed School
Bhopal, India
01.2011

Skills

  • Conduct Quality review and CAPA management meetings
  • Knowledge on method development, method validation, method transfer and r&d stability studies
  • Knowledge on medical devices ( FDA & EU)
  • Knowledge of GXP guidelines and ISO standards
  • Profound ability to work individually and in a team
  • Active interaction with other cross functional departments
  • On- time closure of quality issues
  • Handling and calibration of instruments like weighing balance, pH meter, conductivity meter, TOC analyser, micropipetes and cell density meter
  • Handling of equipments like autoclave, incubators, laminar air flow unit, air sampler water bath and colony counter
  • well- versed with MS-Office

Languages

Hindi
English

Trainingsattended


  • Gemba walk awareness
  • ALCOA, ALCOA+, GMP refresher training, good documentation practices, EHS related trainings

Personal Information

  • Date of Birth: 03/03/93
  • Gender: Female
  • Marital Status: Married
  • Religion: Hindu

Timeline

QMS specialist

Syngene international private limited
03.2021 - 10.2023

Scientist

Anthem biosciences Pvt ltd
01.2017 - 03.2021

Master of Science - Biotechnology

VIT University

Bachelor of Science - Biotechnology

Sri Sathya Sai College For Women

High School Diploma -

ST. Xavier's Senior Secondary Coed School

Similar Profiles

CREATE PROFILE
Suchita Chourey