Summary
Overview
Work History
Education
Skills
Websites
Certification
Accomplishments
References
Timeline
Generic

Vinaya Sara Jacob

Bengaluru

Summary

Quality Control Microbiologist with experience in pharmaceutical quality systems, regulatory compliance, and scientific documentation, adept in GMP practices, GCP, data integrity, and cross-functional collaboration. Currently upskilling in Clinical Research, Data Management and Pharmacovigilance with a strong interest in transitioning to roles within the clinical research and healthcare domain. Committed to ensuring compliance, accuracy, quality in clinical and regulatory environments.

Overview

5
5
years of professional experience
1
1
Certification

Work History

Senior Executive (Quality Control Microbiology)

Biocon Biosphere Limited
Bengaluru
01.2025 - 07.2025
  • Played a key role in setting up a new microbiology lab, including equipment qualification (IQ, OQ, PQ), SOP development and protocol preparation ensuring regulatory compliance with GMP guidelines.
  • Collaborated with engineering, QA and validation teams to establish workflows and documentation systems.
  • Performed routine microbial testing ensuring compliance with regulatory standards.
  • Ensured the lab met audit-readiness standards during setup and routine operations.

Executive (Quality Control Microbiology)

Steriscience Specialties Private Limited (Formerly Viatris Inc.)
Bengaluru
11.2020 - 12.2024
  • Conducted microbiological trend analysis and prepared comprehensive review reports to support GMP compliance.
  • Performed microbial identification using the VITEK-2 Compact Identification System; maintained and preserved microbial cultures.
  • Executed water testing procedures, including microbial analysis and Bacterial Endotoxin Testing (BET).
  • Participated in various validation activities related to microbiological controls and cleanroom environments.
  • Utilized MODA software for the documentation and release of environmental monitoring data and handled sampling, microbiological analysis, and release of consumables through SAP system.
  • Participated in internal and external audits with a strong understanding of current regulatory guidelines.

QC Microbiology Trainee

Steril-gene Lifesciences Private Limited
Puducherry
02.2020 - 06.2020
  • Conducted microbial identification and maintained microbial cultures to ensure optimal viability for testing and validations.
  • Managed the preparation of microbiological media and performed growth promotion tests to ensure media quality and reliability.

Education

Master of Science - Applied Microbiology

Vellore Institute of Technology
Vellore, Tamil Nadu
06.2020

Bachelor of Science - Microbiology

Madras Christian College
Chennai, Tamil Nadu
05.2018

Skills

  • Good Clinical Practices (GCP)
  • GMP Compliance
  • Data Integrity
  • SOP Documentation
  • Audit support and compliance
  • Clinical Trial and Pharmacovigilance Basics
  • MS Excel
  • MS Word
  • Powerpoint
  • Attention to Detail
  • Time Management
  • Team Collaboration

Websites

Certification

Advanced Program in Clinical Research and Management by Clini India

Accomplishments

Received certificate of achievement in recognition of performance exceeding target for the month (April 2024, June 2024, July 2024).

References

References available upon request.

Timeline

Senior Executive (Quality Control Microbiology)

Biocon Biosphere Limited
01.2025 - 07.2025

Executive (Quality Control Microbiology)

Steriscience Specialties Private Limited (Formerly Viatris Inc.)
11.2020 - 12.2024

QC Microbiology Trainee

Steril-gene Lifesciences Private Limited
02.2020 - 06.2020

Master of Science - Applied Microbiology

Vellore Institute of Technology

Bachelor of Science - Microbiology

Madras Christian College

Similar Profiles

CREATE PROFILE
Vinaya Sara Jacob