Summary
Overview
Work History
Education
Skills
Certification
Timeline
Success Stories
Generic

Siddhi Varia

Toronto,ON

Summary

Dynamic clinical research professional with over five years of expertise in clinical research operations, quality systems, and regulatory compliance. Proven track record in managing over 20 site audits to ensure adherence to ICH-GCP, GMP, and global regulatory standards, demonstrating proficiency in reviewing regulatory documentation and preparing comprehensive submissions that enhance compliance initiatives. Extensive hands-on experience includes GCP documentation, plant walkthrough, validation support, and maintaining accurate logbook entries for inspection readiness. Strong problem-solving abilities, analytical skills, and effective communication strategies drive quality improvement and ensure timely project execution across cross-functional teams.

Overview

5
5
years of professional experience
1
1
Certification

Work History

Quality Assurance Auditor

CBCC Global Research
01.2023 - 01.2024
  • Conducted site, vendor, and system audits to ensure GCP and GDP compliance, resulting in strengthened quality oversight and enhanced regulatory readiness.
  • Reviewed and audited regulatory documents including protocols, informed consent forms, case report forms, adverse event data, trial Master file contents, ethics committee data, and Quality Management System data, resulting in improved documentation accuracy, regulatory compliance, and readiness for inspections.
  • Scheduled and executed 15+ yearly audits.

Quality Assurance Auditor

Cliantha Research Limited
01.2020 - 01.2023
  • Audited receipt, labeling, shipping, retrieval, and logbook record review of Investigation products, as well as CoAs and GMP documentation, improving accuracy and reliability in record-keeping.
  • Ensured alignment with regulatory standards and operational needs by collaborating with internal stakeholders to develop, revise, and review Quality Management System (QMS) components, including SOPs, work instructions, regulatory documents, risk management tools and training materials, which improved compliance readiness and streamlined operational processes.

Clinical Research Coordinator

Neo Med Research
01.2019 - 01.2020
  • Drafted responses to regulatory and sponsor queries, ensuring clear communication and expediting issue resolution.
  • Streamlined training workflows and improved oversight by initiating training plan creation and managing the training database to track completion, compliance, and audit readiness.

Education

Graduate Certification - Pharmaceutical Regulatory Affairs & Quality

Seneca Polytechnic
Canada Ontario

Master of Science - Microbiology

Nirma University
05-2018

Bachelor of Science - Microbiology

Gujarat University
05-2016

Skills

  • Good Clinical Practice (ICH-GCP)
  • Good Documentation Practice (GDP)
  • Quality Assurance
  • Documentation of regulatory standards
  • SOP Management
  • Interpersonal skills
  • Oral and written communication skills

Certification

Good Clinical Practise (year 2025)

Timeline

Quality Assurance Auditor

CBCC Global Research
01.2023 - 01.2024

Quality Assurance Auditor

Cliantha Research Limited
01.2020 - 01.2023

Clinical Research Coordinator

Neo Med Research
01.2019 - 01.2020

Graduate Certification - Pharmaceutical Regulatory Affairs & Quality

Seneca Polytechnic

Master of Science - Microbiology

Nirma University

Bachelor of Science - Microbiology

Gujarat University

Success Stories

While working in the Quality Department at Cliantha Research Limited, I took the initiative to suggest innovative ideas and contributed to document review processes, identifying gaps within the system. As a result of these contributions, I was honored with a Spot Recognition Award.

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Siddhi Varia