Summary
Overview
Work History
Education
Skills
Affiliations
Languages
Certification
Accomplishments
References
Timeline
Generic
Likitha Kumar

Likitha Kumar

Tiruvannamalai

Summary

Accomplished executive with expertise in regulatory compliance and audit readiness. Proven success in managing validation lifecycle activities and leading cross-functional compliance processes, ensuring adherence to ISO standards and FDA regulations. Results-driven Quality Assurance Specialist with proven expertise in validation, documentation control (e-QMS and paper-based), and process validation within regulated medical device and pharmaceutical environments. Skilled in handling external audits, customer complaints, CAPA implementations, and aligning operations with ISO 13485, 21 CFR Part 11, and EU MDR 2017/745. Experienced in DHF/DMF documentation, SAP-QMS integration, and conducting robustness studies, shelf-life validations, and BMR reviews, ensuring end-to-end product quality and compliance.

Overview

3
3
years of professional experience
1
1
Certification

Work History

Executive - Quality

Doctor Pack India Private limited
Bangalore
11.2022 - Current
  • Validation: Led validation lifecycle activities (IQ, OQ, PQ) for injection blow molding machines, automated assembly machines, vision inspection systems, and CSV for e-QMS platforms (QT9), ensuring compliance with GAMP 5 and FDA 21 CFR Part 11 requirements.
  • External Audit & Regulatory Compliance Support: Successfully handled regulatory (ISO 13485, ISO 9001, EU MDR) and customer audits, ensuring document readiness, audit observations closure, and proactive compliance tracking.
  • Customer Complaint Handling and Root Cause Analysis: Managed the investigation of customer complaints, coordinated cross-functional CAPA processes, and ensured robust documentation of deviations, non-conformities, and 5-Why Root Cause Analysis.
  • Document Control & Change Control (Hybrid QMS): Oversaw end-to-end Document Control processes in both electronic (e-QMS – QT9, SAP) and paper-based systems, including Change Control impact assessments, procedural revisions, version control, and document lifecycle tracking.
  • SOPs, Work Instructions, and QSP Development: Drafted, revised, and controlled Standard Operating Procedures (SOPs), Work Instructions (WIs), and Quality System Procedures (QSPs) to align with evolving regulatory and operational requirements.
  • Design History File (DHF) & Device Master File (DMF) Documentation: Supported compilation and structuring of DHF & DMF records for medical device regulatory submissions, ensuring traceability and compliance with design control requirements.
  • Product Robustness & Shelf-Life Studies: Executed robustness studies, accelerated and real-time shelf-life testing, and documented comprehensive validation reports for product stability verification.
  • Batch Manufacturing Record (BMR) Review & Release: Conducted detailed BMR reviews, verified AQL sampling results, ensured accurate documentation, and supported batch release approvals in alignment with customer and regulatory standards.
  • Implementation of SAP and QT9 e-QMS Systems: Supported SAP integration for production and quality workflows, and facilitated configuration and validation of QT9 e-QMS modules, including training end users for effective system adoption.

Education

B. Tech - Biotechnology

Arunai Engineering College
Thiruvannamalai
06-2022

HSC -

Paavai Vidyashram
Namakkal
06-2018

SSLC -

Kendriya Vidyalaya
Thiruvannamalai
06-2016

Skills

  • Document control
  • Root cause analysis
  • Regulatory compliance
  • Customer relationship management
  • Audit readiness
  • Product stability testing
  • Continuous improvement
  • Effective communication
  • Cross-functional collaboration
  • Quality system management
  • Customer service
  • Flexible and adaptable
  • Training & Development
  • Collaboration

Affiliations

  • Listening to music

Languages

Tamil
First Language
Telugu
Proficient (C2)
C2
Hindi
Advanced (C1)
C1
Kannada
Intermediate (B1)
B1

Certification

  • ISO 13485:2016 Internal Auditor CertificationTÜV SÜD South Asia Pvt. Ltd. Completed: May 2024
  • ISO 14001:2015 Internal Auditor Certification (Environmental Management System)SGS India Pvt. Ltd. Completed: April 2025
  • ISO 45001:2018 Internal Auditor Certification (Occupational Health & Safety Management System)SGS India Pvt. Ltd. Completed: April 2025
  • EU MDR 2017/745 – Medical Device Regulation (Fundamentals & Compliance Awareness) Completed: [Month Year] (You can fill exact month, e.g., July 2025)
  • Mastering ISO 9001:2015 Quality Management System (Accredited)Quality Gurus Inc. Completed: Oct 2024
  • Mastering ISO 9001:2015 Quality Management System – Udemy Program Completed: Oct 2024
  • Biological Indicators for Sterilization & Spore TestingPharma Skill Craft Completed: Jan 2025
  • Quality improvement and management board infinity (Coursera) completed: Oct 2024

Accomplishments

  • Has won “Gem of the Week” award for performing consistently and efficiently
    during the due time in “Intensive course on Recombinant DNA Technology” at Azyme biosciences Private Limited, Bangalore in November 2019.
  • Has won the proficiency award for excelling in academics for the year 2021-
    2022

References

References available upon request.

Timeline

Executive - Quality

Doctor Pack India Private limited
11.2022 - Current

B. Tech - Biotechnology

Arunai Engineering College

HSC -

Paavai Vidyashram

SSLC -

Kendriya Vidyalaya

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Likitha Kumar