Venkata Navya Lakshmi Gutta
Chicago
Summary
Detail-oriented Quality Assurance (QA) Associate with over 3 years of experience in the pharmaceutical and healthcare domains, specializing in quality systems, regulatory compliance, and process improvement. Proficient in managing batch documentation, deviation investigations, CAPA implementation, and audit readiness in accordance with FDA, GMP, and MHRA guidelines. Experienced in coordinating with QC, R&D, and regulatory teams to ensure product quality, safety, and consistency across manufacturing and analytical processes. Strong understanding of GMP, HIPAA, and 21 CFR Part 11 compliance, with a proven ability to maintain high standards of quality and operational efficiency in a regulated environment.
Overview
6
6
years of professional experience
1
1
Certification
Work History
QA Associate- Healthcare & Pharmaceutical operations
Mindstack technologies
Bloomington
11.2024 - Current
- Supported Quality Assurance functions, ensuring compliance with FDA, GMP, and MHRA regulatory standards.
- Reviewed and approved batch manufacturing records (BMR), analytical data, and Certificates of Analysis (COAs) before product release.
- Assisted in deviation investigations, CAPA implementation, and change control management to drive continuous quality improvement.
- Conducted internal audits and supported external inspections, maintaining audit-ready documentation and ensuring timely closure of findings.
- Collaborated cross-functionally with R&D, QC, and regulatory teams to uphold quality standards throughout product development and manufacturing.
- Supported stability study documentation, verified sample management, and performed analytical data trending for quality review.
- Monitored and validated equipment calibration and environmental conditions to maintain product integrity and laboratory compliance.
- Participated in automating stability testing processes by integrating QA reviews with digital systems, enhancing document traceability.
- Developed standardized QA checklists and deviation logs, reducing batch release turnaround time by 25%.
- Coordinated with IT and QC teams to implement electronic document control for BMRs, improving audit readiness and data traceability.
Clinical Data & LIMS Analyst
Sanity Staffing
Marlborough
01.2024 - 05.2024
- Utilized LIMS to consolidate and validate lab records for clinical trials and regulatory reporting.
- Automated QC documentation, improving data accuracy and reducing turnaround time by 30%.
- Ensured accurate sample registration, chain of custody, and audit trails in coordination with lab and IT teams.
- Analyzed EHRs, surveys, and claims data to identify trends and service gaps.
- Developed HIPAA-compliant reporting tools and predictive models, enhancing decision-making and reducing reporting time by 30%.
Quality Control Analyst
Alapati Pharma
07.2020 - 06.2022
- Worked as a Quality Analyst at Alapati Pharma, ensuring pharmaceutical product quality, safety, and regulatory compliance with FDA, MHRA, and GMP standards.
- Developed and maintained QA systems and SOPs, improving consistency and reducing process deviations across production.
- Conducted quality checks on raw materials, intermediates, and finished products, maintaining audit-ready documentation and supporting successful inspections.
- Led investigations into deviations and complaints, implementing effective CAPA, managing change control, and coordinating batch releases with cross-functional teams.
- Trained new QA staff and collaborated with R&D, regulatory, and production teams to align quality standards and enhance operational efficiency.
- India
Education
Master’s - healthcare informatics
Governors State University
Chicago, ILBachelor's - Pharmacy
Narasaraopeta Institute of Pharmaceutical Sciences (NIPS)
Narasaraopet, IndiaSkills
- Batch Manufacturing Record (BMR) review and approval
- Deviation investigations
- CAPA implementation
- Change control management
- Batch release management
- Healthcare Data Management
- Cerner EHR
- Meditech EHR
- Pharmacovigilance (PV)
- Clinical Data Management (CDM)
- Clinical Research
- Good Clinical Practice (GCP)
- Good Manufacturing Practice (GMP)
- HIPAA Compliance
- Quality Management Systems
- Pharma QC Equipment Handling
- Statistical Techniques
- Internal and External Audits
- Stability Study Documentation
- Equipment Calibration and Environmental Monitoring
- FDA
- MHRA
Certification
- Certificate of completion in LIMS
- Advanced certification in clinical research, CDM, and PV
- Certificate of completion in Electronic Health Records (EHR)
- Google Analytics for Beginners – Certificate of Completion, 12/22
- AI in Pharmacy Certification, Indian Institute of Technology (IIT) Madras, 01/20
Research And Publications
- The Role of Artificial Intelligence in Pharmacy, Article, 2021, Explored AI's applications in drug discovery, patient care, pharmaceutical automation, and personalized medicine.
- Formulation and Evaluation of Glimepiride Floating Microspheres, Conducted experimental research focused on controlled drug delivery using gastro-retentive microsphere systems.
Technical Skills
Batch Manufacturing Record (BMR) review and approval, deviation investigations, CAPA implementation, change control management, batch release management, Healthcare Data Management, Cerner EHR, Meditech EHR, Pharmacovigilance (PV), Clinical Data Management (CDM), Clinical Research, Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), HIPAA Compliance, Quality Management Systems, Pharma QC Equipment Handling, Statistical Techniques, Internal and External Audits, Stability Study Documentation, Equipment Calibration and Environmental Monitoring, FDA, MHRA, GMP
Timeline
QA Associate- Healthcare & Pharmaceutical operations
Mindstack technologies
11.2024 - Current
Clinical Data & LIMS Analyst
Sanity Staffing
01.2024 - 05.2024
Quality Control Analyst
Alapati Pharma
07.2020 - 06.2022
Master’s - healthcare informatics
Governors State University
Bachelor's - Pharmacy
Narasaraopeta Institute of Pharmaceutical Sciences (NIPS)