Summary
Overview
Work History
Education
Skills
Certification
Timeline
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TEJA TUMU

Validation Analyst
Findlay,Ohio

Summary

Accomplished Validation Analyst with a proven track record at Teva Pharmaceuticals, enhancing data-driven decision-making and regulatory compliance through expert validation protocols and rigorous documentation review. Mentored teams for quality assurance excellence at Intertek India Pvt. Ltd, showcasing leadership and CAPA management skills. Achieved significant process improvements, embodying a commitment to quality and efficiency.

Professional validation analyst equipped for excellence in ensuring compliance and accuracy in processes. Skilled in quality assurance, data analysis, and risk assessment. Strong focus on team collaboration and achieving results, with flexible approach to changing needs. Reliable and adept at problem-solving, with keen eye for detail and dedication to maintaining high standards.

Overview

3
3
years of professional experience
5
5
Certifications
1
1
Language

Work History

Validation Analyst

Teva Pharmaceuticals
06.2024 - Current
  • Developed customized validation reports, enabling stakeholders to make informed decisions based on accurate data insights.
  • Collaborated closely with Quality Assurance teams during routine audits to showcase adherence to both internal policies as well as external regulations.
  • Supported regulatory compliance efforts through diligent adherence to industry best practices and guidelines for validation activities.
  • Collaborated with cross-functional teams to ensure consistent application of validation standards across projects.
  • Validated the Computer Systems for compliance with 21 CFR Part 11 and cGXP regulatory standards that include automatic date-time entry, multilevel password security and secure system sign on features.
  • Gathered User Requirement Specifications (URS) and System Requirement Specifications (SRS).
  • Reviewed and documented the Standard Operating Procedures for every validation system in compliance with the FDA regulations.
  • Developed validation protocols such as IQ’s, OQ’s and PQ’s that form a part of the Validation Master Plan.
  • Developed the Dashboard to keep track of the test activities.
  • Reported issues using JIRA and documented incidents reports to rectify them during validation.
  • Maintained and Updated the Requirement traceability Matrix to map the test cases to the requirements.
  • Performed Gap Analysis of the systems and conducted risk analysis for both system and individual critical functions.
  • Participated in documentation of Validation Summary Reports

Quality Assurance Specialist

Intertek India Pvt.Ltd
10.2021 - 05.2022
  • Promoted a culture of continuous improvement within the organization by leading training sessions on various aspects of quality control methodologies.
  • Mentored junior QA specialists, fostering a culture of continuous learning and professional growth.
  • Achieved timely resolution of non-conformance issues by implementing corrective action plans working closely with relevant departments.
  • Educated employees on specific QA standards and confirmed maintenance of standards.
  • Utilized root cause analysis techniques to identify underlying issues contributing to product defects or customer complaints.
  • Enhanced efficiency of QA department, introducing metrics-driven performance evaluations.

Education

Master of Science - Health Informatics

The University of Findlay
Findlay, OH
05.2001 -

Bachelor of Science - Biotechnology

Koneru Lakshmiah University
Vijayawada, India
05.2001 -

Skills

Documentation review

Certification

Regulatory Affairs

Timeline

Validation Analyst

Teva Pharmaceuticals
06.2024 - Current

Quality Assurance Specialist

Intertek India Pvt.Ltd
10.2021 - 05.2022

Master of Science - Health Informatics

The University of Findlay
05.2001 -

Bachelor of Science - Biotechnology

Koneru Lakshmiah University
05.2001 -

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TEJA TUMUValidation Analyst