Summary
Overview
Work History
Education
Skills
Certification
Audit Experience
Languages
Disclaimer
Personal Information
Timeline
Generic
Tarun Bansal

Tarun Bansal

Narela

Summary

A highly adaptable and results-driven Quality Assurance & Regulatory Affairs professional with over 17 years of experience in the Pharmaceutical, Medical Device, and In-Vitro Diagnostics (IVD) industry. Proven expertise in implementing Quality Management Systems (QMS), ensuring regulatory compliance, and optimising quality processes to enhance product safety and effectiveness. Skilled in ISO 13485-2016, ISO 9001-2015, EU MDR 2017, Indian MDR 2017, MDSAP, 21 CFR Part 820.

Overview

16
16
years of professional experience
1
1
Certification

Work History

QA/RA Manager

Peters Surgical India Private Limited
04.2024 - 08.2025
  • Lead the QA/RA department.
  • Lead the QC department.
  • Lead the validation team.
  • Review the EU MDR documentation.
  • Lead the QMS implementation and compliance.

QA/RA Manager

Light Tree Technology India Private Limited
12.2021 - 12.2023
  • Lead the QA/RA department.
  • Review the QC documentation.
  • Lead the validation team.
  • Review the QMS documentation.
  • Lead the QMS implementation and compliance.

Sr. Manager (QA/RA)

Rhysley Private Limited
05.2020 - 11.2021
  • Lead the QA/RA department.
  • Review the QC documentation.
  • Lead the validation team.
  • Review the QMS documentation.
  • Lead the QMS implementation and compliance.

Asst. Manager QA

Auxein Medical Pvt. Ltd.
07.2019 - 04.2020
  • Lead the QA/RA department.
  • Review the QC documentation.
  • Lead the validation team.
  • Review the QMS documentation.
  • Lead the QMS implementation and compliance.
  • Handle the Mechanical Testing NABL Lab.

QA Manager

Supermax Drugs & Pharmaceutical Pvt. Ltd.
02.2017 - 06.2019
  • Lead the QA/RA department.
  • Review the QC documentation.
  • Handle the customer and regulatory audit.
  • Lead the validation team.
  • Lead the QMS implementation & compliance.

Pharmacist

Geeta Medicoz
07.2013 - 01.2017
  • Lead the pharmacy operation.
  • Supplier & customer handling.
  • Handle the sale & purchase of drugs.
  • Handle the inventory control.

Analytical Chemist

Polymedicure Ltd.
09.2009 - 06.2013
  • Handle the QA/QC department documentation.
  • Handle the moulding department quality task.
  • Lead the IPQC team.
  • Lead the validation team.
  • Part of the Kaizen team.
  • Achieved the Kaizen Project.

Education

Bachelor of Pharmacy -

M.D. University
07-2009

Secondary High School -

CBSE Board
05-2005

High School -

CBSE Board
05-2003

Skills

  • Problem solving
  • Lead auditor for MDQMS & QMS
  • Documentation management
  • Risk assessment
  • Quality assurance
  • Validation processes
  • Process improvement
  • Project management
  • Team leadership
  • Office 365
  • Regulatory compliance

Certification

  • Diploma in Information Technology, LBSTI, Delhi, 2009
  • Lead auditor for ISO 9001:2015, SGS India Pvt. Ltd., 2017
  • Internal auditor for ISO 13485:2016, SGS India Pvt. Ltd., 2017
  • Fundamentals & Readiness for MDSAP:2017, BSI Group India Pvt. Ltd., 2019
  • Implementation of European MDR:2107, BSI Group India Pvt. Ltd., 2020
  • Lead auditor for ISO 13485:2016, BSI Group India Pvt. Ltd., 2020
  • ISO 14971:2019 Risk Management for Medical Devices Requirements, BSI Group India Pvt. Ltd., 2023
  • Registered pharmacist with Delhi pharmacy council, 08/2009

Audit Experience

  • ISO 13485:2016
  • ISO 9001:2015
  • MDSAP:2017
  • EU MDR 2017 (CE Marking)
  • Customer & Supplier Audits
  • WHO GMP
  • US FDA 510k
  • CDSCO & NABL Mechanical Lab Testing

Languages

  • English
  • Hindi

Disclaimer

I hereby declare that all the above information furnished about me is true to the best of my knowledge and belief.

Personal Information

  • Expected Salary: Negotiable
  • Date of Birth: 12/22/87
  • Gender: Male
  • Nationality: Indian
  • Marital Status: Married
  • Religion: Hindu

Timeline

QA/RA Manager

Peters Surgical India Private Limited
04.2024 - 08.2025

QA/RA Manager

Light Tree Technology India Private Limited
12.2021 - 12.2023

Sr. Manager (QA/RA)

Rhysley Private Limited
05.2020 - 11.2021

Asst. Manager QA

Auxein Medical Pvt. Ltd.
07.2019 - 04.2020

QA Manager

Supermax Drugs & Pharmaceutical Pvt. Ltd.
02.2017 - 06.2019

Pharmacist

Geeta Medicoz
07.2013 - 01.2017

Analytical Chemist

Polymedicure Ltd.
09.2009 - 06.2013

Bachelor of Pharmacy -

M.D. University

Secondary High School -

CBSE Board

High School -

CBSE Board

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