BHARATHI SHANMUGA BABU
Alpharetta,GA
Summary
Experienced Quality Control Analyst with comprehensive understanding of quality control processes, qualifications, and hands-on experience in microbial testing, in-process quality control test methods, validations, and stability studies. Proven ability to handle multiple tasks concurrently and meet deadlines. Collaborative team player who is self-motivated and can quickly prioritize and make decisions. Proficient in Microsoft products including Excel, Word, and PowerPoint.
Overview
16
16
years of professional experience
Work History
Chemist
Aavis Pharmaceuticals
Atlanta
09.2023 - 12.2024
- Performed tasks according to approved SOP’s, methods and procedure in compliance with cGMP, FDA regulation
- Maintained a clean, organized work environment conducive to efficient operations while adhering to safety regulations
- Involved in Raw material testing of API
- Performed BD, TD, TSA, Moisture content, LOD, ROI and others techniques involved in testing of Raw material
- Performed testing of In-process, Finished product using analytical instruments as per the test methods
- Performed packing material testing as per test method and SOP’s
- Performed Assay, uniformity and disintegration tests
- Responsible for daily calibration on testing equipment
- Received and maintained test samples, reagents and reference standard used in laboratory as per approved procedures
- Maintained log books for sample receiving and tracking on daily basis
- Involved in receiving cleaning samples from production and testing using detergents
- Maintained accurate and legible laboratory logbooks and testing documentation in accordance with SOP’s
Quality Control Analyst
Ascent Pharmaceuticals
03.2022 - 07.2023
- Involved in routine analysis of finished products and packing materials
- Improved product quality by conducting thorough inspections and identifying defects in materials
- Maintained a clean, organized work environment conducive to efficient operations while adhering to safety regulations
- Performed routine maintenance and calibration on testing equipment
- Received and maintained test samples, reagents and reference standard used in laboratory as per approved procedures
- Recorded and organized test data for report generation and analysis
- Leveraged analytical tools such as HPLC, FTIR, UV/Vis spectroscopy for precise characterization of finished products
- Coordinated and performed internal and external audits to ensure compliance with GMP
- Performed qualitative and quantitative analysis of finished products
- Collaborated with production teams to identify areas for improvement and implement corrective actions for better product outcomes
- Inspected incoming products for adherence to labeling laws and company quality standards
- Participated in Product Development/R&D/Validation to provide Quality Assurance input with respect to compliance to cGMP requirements
Quality Control Associate
S.M Pharmaceuticals
BANGALORE, INDIA
03.2015 - 05.2017
- Managed calibration schedules for test equipment used in evaluating product conformance, assuring accurate results were recorded consistently
- Maintained accurate documentation of all quality control activities, ensuring proper record-keeping for audit purposes
- Enhanced customer satisfaction by ensuring products met or exceeded expectations through diligent quality checks
- Reduced defects by implementing rigorous testing methods and maintaining strict adherence to industry standards
- Participated in ongoing education and training programs, staying current with industry trends and best practices in quality control
- Collected and analyzed data to measure effectiveness of quality control processes
- Inspected raw materials and finished products to verify quality and disposed items that did not meet safety requirements
Quality Control Officer
Medreich Limited
Bengaluru, India
02.2011 - 07.2013
- Performed routine analyses to evaluate quality of raw materials, in-process materials, stability samples, packaging materials and finished products and ensure compliance with established standards
- Involved in evaluating, maintaining and storing reference standards
- Responsible for ensuring correct labeling of containers of material and products
- Performed stability testing of active ingredients and finished products
- Participating in complaint investigation and environmental monitoring
- Maintained lab documents according to GLP guidelines, current USP and filled up log files regularly
- Performed assay, dissolution, content uniformity, blend uniformity, impurity, disintegration and other tests
- Involved in maintenance of water system by sampling, testing, releasing along with log book entry and documentation and record tracking
- Collected samples during production using sampling devices and tested randomly to determine in-process product quality
- Recorded inspection and test data such as weights, temperatures, grades and quantities inspected and graded
- Presented clear, organized data in graphs, charts, tables and written reports
- Performed calibration, maintenance and routine sample analysis of the laboratory equipment
- Conducted microbial test for the raw material and finished product
- Performed Gram stain, air viable monitoring, particulate monitoring, viable surface sampling and growth promotion testing of raw materials
- Ensuring of various compliance quality measures such as GLP/GMP by maintaining documentation/records
- Received and maintained test samples, reagents and reference standards used in the laboratory as per approved procedures
Quality Control Associate
Stallion Pharmaceutical Pvt Ltd India
Bangalore, India
06.2009 - 02.2011
- Conducted routine sampling and laboratory analysis of pharmaceutical raw materials, bulk formulated product and finished goods
- Performed instrumental analysis using UV-visible spectrophotometer, kar-l fisher, etc
- Maintenance and daily verification of all instrumental log books
- Ensure lab cleanliness and safety standards are maintained
- Performed calibration and maintenance activities on a wide range of QC instruments and equipment
- Participated in internal assessments and audits
- Receiving and maintenance of reference standards
- Responsible for maintaining all quality logs
- Operated, calibrated pH Meter and conductivity meter, Oakton CON 510 to measure pH of prepared solutions
- Performed visual inspection of finished products
Education
Master of Science - Biotechnology
CMR INSTITUTE OF MANAGEMENT STUDIES
INDIA,BANGALORE2009
Bachelor of Science - Biotechnology
RJS FIRST GRADE COLLEGE
INDIA,BANGALORE2007
Skills
- In-process quality control test methods
- Stability studies
- MS office proficiency
- CGMP
- Chemical and biological safety procedures
- Laboratory Equipment Calibration
- Microbial Testing
- Analytical Skills
- Excellent Communication
Timeline
Chemist
Aavis Pharmaceuticals
09.2023 - 12.2024
Quality Control Analyst
Ascent Pharmaceuticals
03.2022 - 07.2023
Quality Control Associate
S.M Pharmaceuticals
03.2015 - 05.2017
Quality Control Officer
Medreich Limited
02.2011 - 07.2013
Quality Control Associate
Stallion Pharmaceutical Pvt Ltd India
06.2009 - 02.2011
Master of Science - Biotechnology
CMR INSTITUTE OF MANAGEMENT STUDIES
Bachelor of Science - Biotechnology
RJS FIRST GRADE COLLEGE