BHARGAVI DUBAY J
Bangalore
Summary
Quality Assurance Analyst with proven track record in managing eQMS at IQVIA, ensuring adherence to regulatory standards. Expertise in audit management and process improvement enhances operational efficiency and stakeholder communication. Proficient in SmartSolve and data analysis, successfully implements corrective actions to promote a culture of quality and accountability.
Overview
8
8
years of professional experience
1
1
Certification
Work History
Quality Assurance Analyst
IQVIA
01.2017 - Current
- - Manage electronic Quality Management System (eQMS - SmartSolve) to support global audit lifecycle programs, ensuring compliance with GCP and regulatory standards.
- - Oversee audit/inspection records, including data entry, quality checks, and follow-up on corrective actions (CAPA) for critical/major findings.
- - Generate and distribute audit documentation, status reports, and dashboards to stakeholders, improving transparency and accountability.
- - Develop and implement best practices for eQMS processes, enhancing efficiency and customer service across business units.
- - Provide training and support to staff on SmartSolve usage, ensuring adherence to QA protocols.
- - Maintain QA databases and filing systems, ensuring accurate tracking and electronic documentation storage.
Education
Bachelor of Science - Biotechnology
Sapthagiri College of Engineering
Bangalore01.2017
PUC - PCMB
MES College
01.2013
SSLC -
Jindal Public School
01.2011
Skills
- Tools: SmartSolve, MS Office
- Quality management
- Regulatory compliance
- Audit management
- Data analysis
- Corrective actions
- Process improvement
- Document control
- Stakeholder communication
- Data Analysis: Audit lifecycle tracking, report generation, compliance monitoring
- Biotech Techniques: PCR, ELISA, HPLC, Gel Electrophoresis (from academic background)
Certification
- National Conference: Sustainable Management of Urban Environmental Issues (Dayanand Sagar Institution)
- Industrial Training: Biotech Job Training (Bapuji Institute)
- Internships: Karnataka Antibiotics Ltd, Chlorbios Plant Tissue Culture Lab
- Project: Hydroponics using Dendrobium Fimbriatum
Languages
Languages: English, Hindi, Kannada, Tamil
CORE SKILLS
- Audit Process Management | eQMS (SmartSolve) | Regulatory Compliance (GCP)
- Data Analysis & Reporting | Process Implementation | Quality Assurance
- Documentation Control | Cross-functional Collaboration | Continuous Improvement
TECHNICAL SKILLS
Tools: SmartSolve, MS Office
Data Analysis: Audit lifecycle tracking, report generation, compliance monitoring
Biotech Techniques: PCR, ELISA, HPLC, Gel Electrophoresis (from academic background)
ADDITIONAL DETAILS
Languages: English, Hindi, Kannada, Tamil
Strengths: Analytical, Detail-oriented, Collaborative, Adaptable
Timeline
Quality Assurance Analyst
IQVIA
01.2017 - Current
Bachelor of Science - Biotechnology
Sapthagiri College of Engineering
PUC - PCMB
MES College
SSLC -
Jindal Public School
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