Summary
Overview
Work History
Education
Skills
Certification
Additional Qualifications
Websites
Projects
Interests
Accomplishments
Languages
Timeline
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SHIVANI I

SHIVANI I

Summary

Dedicated and enthusiastic life sciences graduate with foundational knowledge of clinical research processes and regulatory guidelines (ICH-GCP). Trained in quality control, environmental monitoring, and documentation management within pharmaceutical laboratory settings. Familiar with Trial Master File (eTMF) management, Laboratory Information Management Systems (LIMS), and adverse event reporting. Strong analytical skills, attention to detail, and a passion for contributing to the successful conduct of clinical trials. Eager to grow as a Clinical Research Associate by supporting clinical operations, ensuring compliance, and maintaining data quality in a dynamic research environment.

Overview

4
4
years of professional experience
1
1
Certification

Work History

Executive - Quality Control Microbiology

Biocon Limited
08.2023 - Current
  • Executed microbiological testing, including bioburden analysis on samples.
  • Operated VITEK 2 Compact System for rapid microbial identification.
  • Conducted method validation and verification studies to enhance routine testing.
  • Performed scheduled water analysis and environmental monitoring of cleanrooms.
  • Ensured GMP compliance in microbiological activities and supported audit readiness.
  • Accurately documented test data using LIMS and managed inventory via SAP.
  • Monitored adherence to industry regulations and internal policies.

Intern

Biocon Pharma Limited
12.2022 - 05.2023
  • Aided in QC microbiology tasks and GMP-compliant documentation.

Intern

Revathi Medical Center
Tirupur
01.2022 - 12.2022
  • Company Overview: Super speciality Hospital
  • Assisted in microbiology, hematology, molecular biology, and biochemistry.
  • Supported blood bank and dialysis documentation.
  • Gained exposure to clinical sample workflows and diagnostics.

Education

Master of Science - Biotechnology

Vellore Institute of Technology
Vellore, Tamil Nādu
08-2023

Bachelor of Science - Biotechnology

PSG College of Arts And Science
Coimbatore, Tamil Nādu
06-2021

12th - The Nilgiris, Tamil Nādu

Kendriya Vidyalaya Wellington
The Nilgiris, Tamil Nādu
06-2018

10th - The Nilgiris, Tamil Nādu

Kendriya Vidyalaya Wellington
The Nilgiris, Tamil Nādu
06-2015

Skills

SAP and LIMS management

Document management systems

Microbial identification

Environmental monitoring

Clinical trial management

GMP compliance

Regulatory adherence

Microbiological testing expertise

Quality assurance and compliance

Microsoft Office proficiency

Effective communication across teams

Patient safety and data integrity

Certification

Advance Diploma in Clinical Research, ClinoGenesis Research Institute, 07/2025 to 12/2025

Additional Qualifications

  • Pharmacovigilance, Udemy, 2025
  • Clinical Research, Udemy, 2025
  • Entrepreneurship, IIT Madras from NPTEL, 2022
  • Measuring Disease in Epidemiology, Imperial from Coursera, 2020
  • Drug Discovery, UC San Diego from Coursera, 2020
  • Animal Physiology, IIT Kanpur from Swayam, 2020,

Websites

Projects

  • Hydrocarbon degradation
  • Green synthesis of cobalt nanoparticles using seaweed extract.

Interests

  • Clinical research
  • Microbiology
  • Genetics
  • Immunology
  • Forensics

Accomplishments

  • First rank holder in PSG College of Arts and Science.

Languages

  • English (written and spoken)
  • Hindi (written and spoken)
  • Tamil (written and spoken)

Timeline

Executive - Quality Control Microbiology

Biocon Limited
08.2023 - Current

Intern

Biocon Pharma Limited
12.2022 - 05.2023

Intern

Revathi Medical Center
01.2022 - 12.2022

Master of Science - Biotechnology

Vellore Institute of Technology

Bachelor of Science - Biotechnology

PSG College of Arts And Science

12th - The Nilgiris, Tamil Nādu

Kendriya Vidyalaya Wellington

10th - The Nilgiris, Tamil Nādu

Kendriya Vidyalaya Wellington

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SHIVANI I