Megh Bose

About Megh Bose

As a Quality Control Microbiology professional with 2+ years of experience in the pharmaceutical industry, I have developed specialized expertise in microbial testing to ensure compliance with Good Manufacturing Practices (GMP) and FDA regulations. My role involves conducting and validating various microbiological methods to guarantee product safety, sterility, and quality, which are crucial for pharmaceutical manufacturing. I am proficient in performing bacterial endotoxin testing (BET), bioburden analysis, sterility testing, and environmental monitoring, all of which ensure that products meet strict regulatory standards. My expertise extends to validating microbiological methods, where I ensure that testing protocols are accurate, reproducible, and compliant with industry standards. Method validation is key in establishing the reliability of microbiological tests and preventing potential issues during production. In addition to my technical skills, I have experience in overseeing laboratory operations, ensuring that microbiological testing processes run smoothly, efficiently, and within regulatory requirements. I work to maintain a compliant laboratory environment, managing day-to-day testing schedules, ensuring adherence to safety protocols, and documenting all results according to GMP and FDA guidelines. A significant part of my role is managing Quality Management System (QMS) elements related to Quality Control (QC). I handle Standard Operating Procedure (SOP) revisions, change controls, Out-of-Specification (OOS) and Out-of-Trend (OOT) investigations, and deviation management. By collaborating with quality assurance teams, I help ensure that any deviations or issues are addressed promptly and effectively, maintaining high standards of compliance and quality. My strong analytical abilities and dedication to upholding stringent quality standards make me a valuable asset in pharmaceutical manufacturing, contributing to the production of safe and compliant products for patients. My focus on continuous improvement and regulatory adherence ensures that the highest quality is consistently achieved in every aspect of microbiological testing.

Experience

1. Junior Executive

   Harjai Technologies

   Jun 2023 — Present · Bengaluru, IN

   As a Junior Executive in the Quality Control Microbiology department, I play a crucial role in the testing team, ensuring product safety and regulatory compliance through various microbiological analyses and validations. My responsibilities include performing Bacterial Endotoxin Testing (BET) using both gel clot and kinetic methods for water, products, raw materials, and more. I am also involved in water sampling and analysis, preparing trends and worksheets using Caliber LIMS (Version 3.5.0.E).I conduct bioburden testing and method validation for BET and bioburden, ensuring robust and accurate protocols. As part of the Environmental Monitoring Program (EMP), I conduct swab analysis and monitor cleanliness in controlled areas. I also perform sterility testing of products using direct incubation methods to maintain compliance with sterility standards.Additionally, I use the VITEK 2 Compact System for microbial identification, helping to develop the water library. I manage Quality Management Systems (QMS) activities, including SOP revisions, change control, and investigations of Out-of-Specification (OOS) and Out-of-Trend (OOT) results via Veeva Vault. My responsibilities also extend to Microbial Limit Testing (MLT) of raw materials, DHS tunnel validation for depyrogenation, and conducting visual inspections of media fill vials to ensure product integrity and sterility.I contribute to the quality control process through a variety of essential testing and validation activities, ensuring the safety and compliance of pharmaceutical products.

Education

• Pondicherry University

  Master's degree

  2020 — 2022

• University of Calcutta

  Bachelor of Science - BS

  2017 — 2020