Chaithralaxmi Rai
Executive
Bangalore
Summary
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.
Overview
6
6
years of professional experience
4
4
Certifications
1
1
Language
5
5
years of post-secondary education
Work History
Executive
Recipharm Pharmaservices Pvt. Ltd.
Bangalore
05.2022 - Current
- Perform Microbial Limit Test, Preservative Efficacy Test, and Water Activity Test on finished products, APIs, and water samples in compliance with GMP, ISO, and USFDA standards.
- Conduct culture maintenance and culture cryopreservation for microbial reference strains.
- Execute method validation for non-sterile products such as toothpaste and mouthwash, ensuring compliance with pharmacopeial standards.
- Carry out micro kill time studies for oral care products to evaluate antimicrobial efficacy.
- Prepare growth media and perform Growth Promotion Tests to confirm media suitability.
- Manage Laboratory Investigation Reports (LIR) and prepare Corrective and Preventive Actions (CAPA) for deviations and non-conformances.
- Maintain accurate documentation and ensure compliance with GDP, GLP, and regulatory audit requirements.
- Utilize LIMS and Veeva Vault for data management, document control, and regulatory reporting.
- Identified and qualified customer needs and negotiated and closed profitable projects with high success rate.
Analyst
Sequent Research Limited
Mangalore
11.2019 - 05.2022
- Performed Total Organic Carbon (TOC) analysis, Water Activity, Preservative Efficacy Test, Microbial Limit Test, Bacterial Endotoxin Test, and Growth Promotion Test on pharmaceutical products and water samples.
- Prepared microbiological media and validated suitability through media preparation and quality checks.
- Managed culture maintenance and biochemical characterization of microorganisms.
- Utilized LIMS for sample tracking, test data entry, and documentation in compliance with regulatory standards.
- Maintained strict documentation practices aligned with GLP, GDP, and industry guidelines.
- Conducted environmental monitoring of cleanrooms to ensure sterility compliance.
Intern - Microbiology
Sequent Research Limited
Mangalore
04.2019 - 10.2019
- Assisted in microbiological testing, documentation, and daily lab operations.
- Gained hands-on experience with laboratory instruments and microbiological techniques.
- Supported project teams in sample preparation, analysis, and report compilation.
Education
Master of Science - Biotechnology
Mangalore University
Mangalore, India 06.2016 - 06.2018
Bachelor of Science - Biotechnology
Mangalore University
Mangalore, India 06.2013 - 05.2016
Skills
Microbiological Testing & Analysis: Microbial Limit Test, Preservative Efficacy Test, Bacterial Endotoxin Test, Sterility Testing, Water Activity, Total Organic Carbon (TOC) Analysis, Growth Promotion Test, Micro Kill Time Study, Method Validation for Non-Sterile Products, Biochemical Characterisation, Culture Maintenance, Cryopreservation, Cryovial Preparation
Regulatory Compliance & Audits: GMP, GLP, GDP, ISO Standards (ISO/IEC 17025), USFDA, NABL, Customer & Regulatory Audits, LIR, CAPA
Laboratory Techniques & Tools: Growth Promotion Testing, Cleanroom Monitoring, Media Preparation & Validation, Autoclave Operation, UV/Vis Spectrophotometry, LIMS Handling, Veeva Vault
Quality Systems & Documentation: Method Validation, SOP Development, Sampling Plan Validation, Data Presentation, Biohazard Safety, Regulatory Documentation, Scientific Record-Keeping
IT & Technical Skills: Microsoft Excel, Microsoft Word, AWS Cloud Services, DevOps Tools (CI/CD, Docker, Jenkins, Git), Cloud Infrastructure Management
Soft Skills: Problem Solving, Team Collaboration, Process Improvement, Workload Management
Certification
AWS Certified Solutions Architect – Associate
Accomplishments
- 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.
Timeline
Executive
Recipharm Pharmaservices Pvt. Ltd.
05.2022 - Current
Analyst
Sequent Research Limited
11.2019 - 05.2022
Intern - Microbiology
Sequent Research Limited
04.2019 - 10.2019
Master of Science - Biotechnology
Mangalore University
06.2016 - 06.2018
Bachelor of Science - Biotechnology
Mangalore University
06.2013 - 05.2016