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 ProgramCompleted: 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