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
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
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
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
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
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