Summary
Overview
Work History
Education
Skills
Certification
Projects Internships
Disclaimer
Timeline
Generic

Sumaiga Sugunesan

Data Analyst
Chennai

Summary

Compliance-driven Life Sciences professional with 7 years of pharmaceutical industry experience. Specializes in regulatory documentation, data stewardship, change control, and validation lifecycle support. Experienced in managing GxP-compliant systems, ensuring audit-ready documentation, and supporting IT quality initiatives. Proficient in Veeva Vault (Quality & CRM), Trackwise, and Reltio MDM. Strong communication and stakeholder engagement skills to drive quality excellence, continuous improvement, and process ownership.

Overview

9
9
years of professional experience
4
4
years of post-secondary education
1
1
Certification
2
2
Languages

Work History

Analyst Data Steward

AstraZeneca
Chennai
05.2023 - Current
  • Support GxP compliance by managing HCP/HCA profiles in Veeva CRM and processing high volumes of data change requests in Reltio MDM.
  • Conduct root cause analysis and provide quality observations aligned with data integrity principles.
  • Maintain data lifecycle compliance and collaborate with cross-functional teams to improve data governance processes.
  • Utilize SQL queries for extracting and analyzing records to ensure accuracy and regulatory alignment.
  • Contribute to continuous quality improvement and support audit trail reviews and validation-ready records.
  • Delivered clear, actionable observations and offered targeted recommendations for business improvement.
  • Analyzed and interpreted large volumes of data from multiple sources.
  • Educated users on automation systems and features to reduce work time and achieve quality results.
  • Built automated scripts to streamline manual tasks such as report generation.
  • Generated ad hoc reports upon request from stakeholders or clients.

Senior Professional Analyst

GVW Technologies Pvt Ltd
Chennai
01.2018 - 04.2023
  • Owned and maintained procedural and regulatory documents in Veeva Vault Quality.
  • Led document lifecycle activities including creation, review, approval, and obsolescence of validation protocols, change controls, and technical specifications.
  • Created and managed Change Controls in Trackwise as per GxP standards; participated in impact assessments and deviation handling.
  • Authored SOPs and Work Instructions aligning with regulatory and audit expectations.
  • Contributed to validation and regulatory readiness through document control and version history traceability.
  • Provided support during internal audits by maintaining audit-ready documentation and CAPA records.
  • Maintained drugs related document procedures, registries, and records for controlled drugs of Janssen Pharmaceutical company.
  • Performed analysis, documenting, and implementing activities of Pharmacopeia and change control changes in Specifications of LAB and REG and created new Specifications for Excipients and Drug Products.

Medical Record Reviewer

Preludesys Pvt Ltd
Chennai
01.2016 - 01.2017
  • Retrieved patient medical records for Attorneys.
  • Reviewed records for completeness, accuracy, and compliance with regulations.
  • Updated records with demographic data, medical histories, and diagnostic procedures.
  • Maintained accuracy, completeness and security for medical records and health information.

Education

Master of Science - Biochemistry

Ethiraj College For Women
Chennai, India
06.2013 - 03.2015

Bachelor of Science - Biochemistry

Ethiraj College For Women
Chennai, India
06.2010 - 03.2013

Skills

  • IT Compliance & Validation Lifecycle

  • GxP / GMP Documentation

  • Change Control (Trackwise)

  • Risk Impact Assessment (RID)

  • Document & Lifecycle Management (Veeva Vault)

  • Master Data Management (Reltio)

  • Audit Readiness & Quality Monitoring

  • SOP / WI Authoring & Maintenance

  • SQL-based Data Validation & Reporting

  • Stakeholder Engagement & Cross-functional Collaboration

  • Microsoft Office

  • Project Management

  • Documentation and reporting

Certification

Professional Scrum Master I (PSM I), Scrum.org, 10/03/24

Projects Internships

  • UGC project of Biochemical study on the effects of Naringenin on pancreatitis induced diabetes in rats., 2015
  • Internship attended on 'Training in laboratory' in Billroth Hospital., 2014

Disclaimer

I sincerely proclaim that all the particulars mentioned above are true to my belief and I am accountable for its accuracy.

Timeline

Analyst Data Steward

AstraZeneca
05.2023 - Current

Senior Professional Analyst

GVW Technologies Pvt Ltd
01.2018 - 04.2023

Medical Record Reviewer

Preludesys Pvt Ltd
01.2016 - 01.2017

Master of Science - Biochemistry

Ethiraj College For Women
06.2013 - 03.2015

Bachelor of Science - Biochemistry

Ethiraj College For Women
06.2010 - 03.2013

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Sumaiga SugunesanData Analyst