Summary
Overview
Work History
Education
Skills
Software
Timeline
Generic

Dharini Natarajan

IT Quality & Compliance SME in Life Science Domain
Coimbatore

Summary

Accomplished Quality and Compliance Manager with a proven track record in conceiving and implementing effective ideas/ strategies, excelling in document reviews, audit support and analytical thinking. Spearheaded compliance initiatives, significantly enhancing quality standards in entire Computer System Validation, Quality Assurance and Regulatory Compliance.

Overview

14
14
years of professional experience

Work History

Quality and Compliance Manager

Cognizant Technology Solutions, CTS
08.2021 - Current
  • End to end Computer system validation, SDLC documentation - Validate the Deliverables for each phase of the SDLC to ensure the quality of the deliverables
  • Validation Practices with a good understanding of GxP (GMP, GLP& GDP) standards and 21 CFR Part 11.
  • Hands on experience in HP-ALM, JIRA, Veeva Quality document.
  • Expertise in handling Change control, CAPA, Deviation, Incident and Defect management.
  • Mentored the team for Implementation planning, Quality, Compliance, and Good Documentation Practices.
  • Extensively authored, reviewer and Approver for system life cycle documents.
  • Driving organizational process, improvement initiatives.
  • Participating in required forums, meeting to review quality and compliance of application.
  • Prepare application for audits / assessments and provide support during audits / assessments.

Quality and Compliance Analyst

Cognizant Technology Solutions, CTS
12.2018 - 10.2020
  • Manage validated state of IT applications and define Quality Management Process.
  • Responsible for end-to-end CSV process as per client SOP’s.
  • Responsible for review and approve lifecycle documentation for CSV by maintaining the quality and security standards

Quality Analyst Lead

Global Value Web
01.2011 - 12.2018
  • Experience in the process of rolling out new eLIMS (Electronic Laboratory Information Management System).
  • Excellent track record of Business Requirement Gathering & Analysis through all the phases of Master data migration. (Traveled to Rome, Italy for Business requirements gathering).
  • Creation, Change, Deletion of global master data based on approved change requests in Labware and Labvantage LIMS.
  • Pro-actively safeguarding Non-compliance with regards to Client’s regulations and guidelines.
  • Involved in discussions for root cause analysis for incidents and deviations using tools such as 5- Why, Fish bone, Brainstorming.

Education

Bachelor of Science -

Ethiraj College For Women
04.2001 -

Jawahar Higher Secondary School
04.2001 -

Skills

Computer System Validation

Analytical Thinking

Risk Assessments & Mitigations

Compliance documents

Regulatory Compliance & Internal/External Audits support

Continuous Process Improvement/ Enhancements

Agile Methodology

Incidents/ Deviations/ CAPA/ Change Control

Document reviews

Software

JIRA

HP ALM

Veeva Quality Document

ServiceNow

Timeline

Quality and Compliance Manager

Cognizant Technology Solutions, CTS
08.2021 - Current

Quality and Compliance Analyst

Cognizant Technology Solutions, CTS
12.2018 - 10.2020

Quality Analyst Lead

Global Value Web
01.2011 - 12.2018

Bachelor of Science -

Ethiraj College For Women
04.2001 -

Jawahar Higher Secondary School
04.2001 -

Similar Profiles

CREATE PROFILE
Dharini NatarajanIT Quality & Compliance SME in Life Science Domain