Chaithralaxmi Rai

Detail-oriented Microbiologist with over 6 years of experience in pharmaceutical microbiology, quality control, and R&D. Skilled in microbiological testing, method validation, and regulatory compliance in accordance with GMP, GLP, ISO, and USFDA standards. Adept at LIMS and Veeva Vault document/data management, audit preparation, and process improvement. Also certified as an AWS Solutions Architect and DevOps Engineer, with expertise in cloud services, CI/CD pipelines, and IT tools. Proven track record in both laboratory operations and cloud-based solutions, ensuring product safety, data integrity, and operational efficiency.

AWS Certified Solutions Architect – Associate

• Achieved 100% compliance in multiple USFDA and NABL audits through meticulous documentation, LIMS/Veeva Vault data management, and adherence to GMP, GLP, and GDP.
• Successfully performed method validation for non-sterile products (toothpaste, mouthwash) and micro kill time studies for oral care formulations, ensuring regulatory approval for global markets.
• Streamlined microbiological testing workflows, reducing turnaround time by 20% without compromising quality or compliance.
• Led media preparation and Growth Promotion Test validation initiatives, improving reliability of microbial growth detection by 15%.
• Optimized TOC, BET, PET, and MLT testing processes, enhancing accuracy and reproducibility in QC analysis.
• Trained junior microbiologists and lab staff on advanced microbiological techniques, LIMS operations, and documentation best practices, increasing team productivity.
• Contributed to product safety assurance for multiple pharmaceutical and consumer products, directly impacting release of high-quality, compliant batches to global markets.