BHARGAVI PARATE
Chicago,Illinois
Summary
Experienced QC professional with 7 years of hands-on experience with various QC instruments in the pharmaceutical sector. Seeking a transition to biotechnology for a challenging role where I can leverage my analytical skills in innovative research to contribute to the betterment of human health.
Overview
7
7
years of professional experience
Work History
Officer
Lupin Pharmaceuticals Ltd
11.2021 - 08.2022
- Implemented Chemical Management and Standard Management modules of Labware LIMS for quality control, ensuring regulatory compliance and organizational alignment.
- Collaborated with cross-functional teams to gather requirements, design workflows, and configure the system.
- Provided hands-on user training, developed validation protocols, and acted as a subject matter expert on Standard Management within LIMS, optimizing system utilization.
- Oversee deviations and CAPA as necessary, ensuring pharmaceutical standards compliance.
Sr. Executive
Cipla Pharmaceuticals Ltd
10.2019 - 10.2021
- Daily temperature and humidity monitoring in compliance with USP guidelines.
- Maintained storage and distribution of drug products and reference standards per USP Chapter 1079.
- Vial filling under LAF conditions for single usage standards.
- Periodic review and validity checks of reference standards as per USP Chapter 11.
- Performed daily and monthly balance calibration following USP guidelines 41 and 1251 and WHO GMP for standards.
- Managed Change Requests in Cipdox software for traceability.
- Implemented the concept of filling larger vials for non-critical Laboratory standards, aimed at reducing material loss and achieving cost savings.
- Generated the idea of employing digital data loggers for daily temperature and humidity monitoring in the area, thereby mitigating human errors.
Sr. Officer
Intas Pharmaceuticals Ltd
08.2018 - 10.2019
- Review and validate master data in Caliber LIMS to ensure regulatory compliance.
- Maintain records of Quality Control SOPs and coordinated with QA to review and approve new SOPs.
- Prepare master worksheets for different tests of finished products as per Standard Test Procedures (STP) as needed.
- Serve as an L1 level reviewer of master worksheets in Caliber LIMS.
Technical Trainee
Cadila Pharmaceuticals Ltd
05.2015 - 06.2016
- Perform quality control analysis of finished products using a range of instruments including UV spectrophotometer, HPLC, Dissolution, Disintegration, and IR.
- Provide training to newly joined QC analysts on good laboratory practices and instrument operation.
- Enter data for finished batches into LIMS (Laboratory Information Management System).
- Release finished products using SAP (Systems, Applications, and Products in Data Processing).
Analyst
Oasis Test House
01.2015 - 05.2015
- Perform quality control analysis of finished products using a range of instruments including UV spectrophotometer and IR.
- Review worksheets required for testing.
Apprentice
Cadila Pharmaceuticals Ltd
07.2012 - 07.2013
- Analyze newly developed drug products using HPLC and dissolution testing.
- Conduct in vivo and in vitro dissolution studies on developmental drugs
Education
Masters in biotechnology - Biotechnology
Roosevelt University
Chicago, IL12.2024
M.Sc. - Chemistry
Devi Ahilya Vishvavidhyalaya
Indore, MP06.2012
B.Sc. - Chemistry
Gujarat University
Ahmedabad, Gujarat01.2010
Skills
- HPLC Waters (2690 - Alliance, Data processor Empower -2)
- UV Spectrophotometer: Shimadzu 2450, 1700 models
- FTIR: Shimadzu
- Dissolution Tester: Electro lab, Varian (Autosampler)
- Auto Titration: Metrohm, Spectrum lab
- Disintegration Apparatus: Electro lab
- Hardness Tester
- SAP Software
Job Profile
Analysis, Interpretation and Documentation
Roles And Responsibilities
- Validated Labware LIMS 7.0 to ensure pharmaceutical regulatory compliance through IQ, OQ, and PQ.
- Conducted temperature distribution studies for precise instrument conditions.
- Optimized SOPs for streamlined workflow and compliance.
- Calibrated analytical instruments meticulously for accurate results.
- Managed procurement and inventory of Reference standards.
- Reviewed and rectified SOP errors promptly.
- Implemented cost-saving measures for Laboratory standards filling.
- Introduced digital data loggers for continuous monitoring.
- Initiated Change Requests in Cipdox software for procedural updates.
- Analyzed initial and new pharmaceutical products for safety and efficacy.
- Maintained and managed Laboratory Standards meticulously.
- Monitored GLP compliance for quality assurance.
- Conducted essential water analysis.
- Provided comprehensive training to new analysts.
- Proficient in Caliber and Labware LIMS 7.0 Master.
- Entered batch data into LIMS and released products using SAP.
Current Address
4839 N New England Avenue, Chicago, Illinois, 60656
Personal Information
- Date of Birth: 02/21/1990
- Gender: Female
- Nationality: Indian
- Visa Status: F1 Visa holder
Disclaimer
I hereby declare that all the above information is true to the best of my knowledge.
Timeline
Officer
Lupin Pharmaceuticals Ltd
11.2021 - 08.2022
Sr. Executive
Cipla Pharmaceuticals Ltd
10.2019 - 10.2021
Sr. Officer
Intas Pharmaceuticals Ltd
08.2018 - 10.2019
Technical Trainee
Cadila Pharmaceuticals Ltd
05.2015 - 06.2016
Analyst
Oasis Test House
01.2015 - 05.2015
Apprentice
Cadila Pharmaceuticals Ltd
07.2012 - 07.2013
Masters in biotechnology - Biotechnology
Roosevelt University
M.Sc. - Chemistry
Devi Ahilya Vishvavidhyalaya
B.Sc. - Chemistry
Gujarat University
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