Pravallika Vesa
Buford,GA
Summary
Detail-oriented Quality Assurance Specialist experienced in QA review of raw data, analytical documentation, batch records, and stability studies in pharmaceutical chemistry laboratory environments. Achieved compliance with cGMP, FDA regulations, and compendial standards (USP/EP) while maintaining data integrity aligned with ALCOA principles. Leveraged expertise in analytical techniques and QMS tools to enhance quality systems and drive continuous improvement.
Overview
5
5
years of professional experience
Work History
Quality Assurance Specialist
Aavis Pharmaceuticals
Hoschton, GA
08.2023 - Current
- Executed quality assurance review of chemistry laboratory raw data and reports, including analytical worksheets, test summaries, and stability summaries, ensuring compliance with cGMP, FDA guidance, and internal procedures
- Maintained data integrity (ALCOA principles) during documentation review and handling, ensuring accuracy and compliance
- Performed detailed review of raw material analytical data, including pH, moisture content, Loss on Drying (LOD), Residue on Ignition (ROI), particle size, and spectroscopic data (UV, FTIR) across wet and dry chemistry methods
- Reviewed analytical data generated using HPLC, UV-Vis, FTIR, and other wet chemistry methods (USP/IP/EP)
- Ensured all laboratory activities and documentation were performed and recorded in accordance with SOPs, GMP documentation practices, and regulatory requirements
- Participated in quality system activities, including deviation investigations, change control processes, CAPA implementation, and batch record review, supporting compliance and operational integrity
- Identified opportunities for quality process improvements, enhancing efficiency and accuracy of QA data review process
- Authored, reviewed, and updated Standard Operating Procedures (SOPs) and other GMP documentation to maintain compliance and standardization
- Reviewed and verified instrument calibration and maintenance records, ensuring adherence to established procedures and regulatory standards
- Supported and conducted internal audits and inspections, ensuring compliance with quality systems, cGMP requirements, and company policies
- Effectively managed multiple concurrent QA review tasks, consistently meeting strict deadlines while maintaining exceptional attention to detail
- Utilized TrackWise and MasterControl systems for quality management system (QMS) documentation, tracking, and compliance activities
QA Document Review Intern
Aurobindo Pharma
Hyderabad, India
05.2021 - 07.2022
- .Assisted in reviewing chemistry laboratory raw data and documentation, including analytical worksheets, test reports, and stability data for accuracy and completeness.
- Supported quality assurance (QA) data review activities to ensure compliance with cGMP, GLP, and applicable regulatory guidelines (e.g., CDSCO, FDA).
- Verified raw material and finished product test data, including parameters such as pH, moisture content, LOD, assay, and impurity profiles.
- Ensured all documentation adhered to Standard Operating Procedures (SOPs) and Good Documentation Practices (GDP)Assisted in SOP review and revision, ensuring alignment with current regulatory and company standards.
- Participated in batch record review and documentation checks to support product release activities.
- Supported deviation investigations, change control documentation, and CAPA tracking under supervision.
- Verified instrument calibration and maintenance records to ensure compliance with laboratory standardsAssisted in internal audits and inspection readiness activities, ensuring documentation accuracy and traceability.
- Coordinated with Quality Control (QC) and Production teams to resolve documentation discrepancies.
- Managed multiple documentation review tasks while maintaining high attention to detail and meeting deadlines.
Education
Master of Science - Healthcare Informatics
Sacred Heart University
Fairfield, CTDoctor of Pharmacy -
Nirmala College of Pharmacy
IndiaSkills
- Regulatory compliance
- Quality management systems
- SOP development
- QA data review
- Batch record compliance
- Chemistry Laboratory Documentation Review
- Stability & Test Summary Review
- Raw Material Testing & Review
- Instrument Calibration Review
- Analytical Techniques: HPLC, UV-Vis, FTIR
- Wet Chemistry Methods
- Data integrity
Timeline
Quality Assurance Specialist
Aavis Pharmaceuticals
08.2023 - Current
QA Document Review Intern
Aurobindo Pharma
05.2021 - 07.2022
Master of Science - Healthcare Informatics
Sacred Heart University
Doctor of Pharmacy -
Nirmala College of Pharmacy