Summary
Overview
Work History
Education
Skills
Websites
Honours And Awards
Certifications And Diplomas
Timeline
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Anup Bobhate

Trois-Rivières,Canada

Summary

Regulatory Affairs and Quality Assurance professional with 7+ years of experience in pharmaceuticals, biotechnology, and cannabis industries. Proven success in regulatory submissions (CTD, NDS), GMP compliance, SOP development, and quality systems. Experienced in managing audits, documentation, and cross-functional collaboration in alignment with Health Canada, FDA, and ICH standards. Strong background in microbiology, environmental monitoring, data analysis, and risk assessment.

Overview

9
9
years of professional experience

Work History

Quality Control Associate

Kizos Culture
Trois-Rivières, QC
10.2024 - Current
  • Conduct data analysis and maintain GPP-compliant quality control records.
  • Manage and archive quality documentation per GDP standards.
  • Ensure compliance with Health Canada’s Cannabis Act.
  • Support internal/external audits, including document preparation.
  • Develop and enforce SOPs, Work Instructions, and Preventive Control Plans.
  • Identify quality issues and implement process improvements.
  • Maintain strict confidentiality of operations and proprietary data.

Regulatory Affairs Intern

Crown College of Canada
Toronto, ON
04.2024 - 06.2024
  • Prepared submission documents using CTD format aligned with Health Canada.
  • Applied ICH-M4 and Canadian regulatory standards.
  • Drafted regulatory strategy for NDS submissions.
  • Collaborated on documentation and submission planning with project teams.
  • Created Gantt charts and tracked submission timelines.

Process Operator

Teva Canada
Markham, ON
08.2023 - 03.2024
  • Operated equipment and followed GMP, EH&S, and SOPs.
  • Accurately completed GMP documentation and in-process checks.
  • Managed ERP data entry and troubleshooting process parameters.
  • Executed disassembly, cleaning, and reassembly per SOPs.

Executive Microbiologist (QC)

Biocon
Bengaluru, India
07.2020 - 06.2022
  • Conducted QC microbiological testing and environmental monitoring using LIMS in compliance with FDA and USP standards.
  • Performed GPT, microbial ID (VITEK 2), and authored CAPA, OOS, and SOPs to support regulatory audits.

Junior Research Fellow

Prof. M. V. Diabetes Research Centre
Chennai, India
06.2017 - 11.2019
  • Led DBT-funded study on TB and diabetes; designed protocols, managed patient recruitment, and analyzed 1400+ samples.
  • Used IGRA for TB detection and ELISA for cytokine profiling; co-authored peer-reviewed publications.

Research Trainee

Hindustan Unilever Ltd.
Bengaluru, India
04.2016 - 03.2017
  • Researched diabetes-related dysfunction in adipocytes; conducted RT-PCR and ELISA.
  • Collaborated on 3 research projects and prepared analytical reports.

Education

MSc - Regulatory Affairs

Northeastern University
Toronto, ON
06.2024

MSc - Biotechnology for a Sustainable Future

University of East Anglia
UK
09.2012

BTech - Biotechnology

SRM University
India
05.2011

Skills

  • SOPs
  • CAPA
  • Deviation
  • QMS
  • GMP
  • GDP
  • Risk Assessment
  • CTD/NDS submissions
  • Health Canada/FDA/ICH guidance
  • Document Control
  • MES
  • LIMS
  • Harmony Trackwise
  • Knowledge tree
  • SPSS
  • Prism
  • MS Office
  • EM
  • BET
  • GPT
  • VITEK 2
  • MLT
  • GLP
  • ELISA
  • RT-PCR
  • Cell Culture
  • SDS-PAGE
  • Western Blot

Honours And Awards

  • SPOT Performance Award, Biocon, 2022
  • Junior Research Fellowship, DBT, Govt. of India, 2017-2019
  • Student Fellowship, DBT, Govt. of India, 2015-2016

Certifications And Diplomas

  • Biocon-KGI Certificate Program: Biosciences, Biocon Academy, 2020
  • PG Diploma: Protein Expression and Scale-up, JSS College, 2016

Timeline

Quality Control Associate

Kizos Culture
10.2024 - Current

Regulatory Affairs Intern

Crown College of Canada
04.2024 - 06.2024

Process Operator

Teva Canada
08.2023 - 03.2024

Executive Microbiologist (QC)

Biocon
07.2020 - 06.2022

Junior Research Fellow

Prof. M. V. Diabetes Research Centre
06.2017 - 11.2019

Research Trainee

Hindustan Unilever Ltd.
04.2016 - 03.2017

MSc - Regulatory Affairs

Northeastern University

MSc - Biotechnology for a Sustainable Future

University of East Anglia

BTech - Biotechnology

SRM University

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