Bopanna I B
Bengaluru,KA
Summary
Dynamic professional with extensive experience. Excelling in LIMS implementation and data validation. Proven team leadership and problem-solving skills, ensuring compliance and audit readiness. Adept in system integration and documentation, driving efficiency in quality control processes. Recognized for achieving timely project completions and enhancing operational workflows.
Overview
14
14
years of professional experience
Work History
Assistant Manager
Biocon
04.2022 - Current
- Digitization and LIMS implementation with evaluated and coordinated URS preparation
- Validating and approval of LIMS master data for technical usage
- Creation of master data for instruments and implication in LIMS module for routine usage
- Review of Stability study and migration into LIMS module
- CAPA, Incident and OOS investigation and closure through QMS
- Verification of custom field implementation in Empower application
- Creation of about 250 instrument and processing method in Empower application
- Ensured compliance with all safety regulations by conducting regular inspections of equipment/operations
- Audit preparedness and compliance
Senior Executive
Biocon
04.2019 - 03.2022
- Verification of completed data in SAP for approval
- Review of stability protocol for stability inception
- Verification of stability data in Novatek application
- Review of Standard Operating Procedures(SOP) and analysis related Observation Data Sheet(ODS) in Bizapp and DMS application
- Review of product related Certificate of Analysis (COA)
- Review of regular analyzed data of Finished product, Intermediate and Stability samples with analytical instruments located in QC Department.
Executive
Biocon
08.2016 - 03.2019
- Performing analysis in High Pressure Liquid Chromatography, Gas Chromatography instruments
- Performing analysis in SOR, IR and KF coulometer
- Performing analysis for LOD, ROI and solubility parameters.
- Performing analysis for Standard qualification, Raw materials and API
Quality Control - Executive
Semler Research Center
04.2014 - 08.2016
- 100% review and verification of project specific data from Bio-analytical lab
- Complete data archival verification of projects through Analyst software
- Involved in Spot Investigation and to provide immediate Remedial action for failed batches (OOS, OOT or Deviation batches)
- Maintaining of online documentation for analysis and providing analytical support for cost improvement projects
- Analyzed data from testing results to identify trends and recommend corrective actions for product discrepancies
Executive
Omega Healthcare
02.2012 - 03.2014
- Involved in investigation and settlement of medical bills related to US and European countries
- Involved in interaction with doctors and agencies towards clarification for medical bills
Education
Bachelor of Engineering - Biotechnology
NMAMIT
Nitte06-2011
Skills
- Team leadership
- Time management and Prioritization
- Decision-making
- Problem-solving
- System integration
- Flexible and adaptable
- Documentation and Testing
Languages
English
Bilingual or Proficient (C2)
Hindi
Bilingual or Proficient (C2)
Kannada
Bilingual or Proficient (C2)
Kodava Tak
Bilingual or Proficient (C2)
Tamil
Upper intermediate (B2)
Telugu
Upper intermediate (B2)
Timeline
Assistant Manager
Biocon
04.2022 - Current
Senior Executive
Biocon
04.2019 - 03.2022
Executive
Biocon
08.2016 - 03.2019
Quality Control - Executive
Semler Research Center
04.2014 - 08.2016
Executive
Omega Healthcare
02.2012 - 03.2014
Bachelor of Engineering - Biotechnology
NMAMIT