Naga Gayathri Nagabyru
St Louis,MO
Summary
Quality Assurance & Regulatory Affairs professional with 4+ years of experience in the pharmaceutical industry, specializing in API manufacturing and solid oral dosage forms. Proven expertise in GMP compliance, regulatory documentation, and Quality systems including BMR/BPR review, deviation handling, CAPA, and change control. Hands-on experience with internal audits, regulatory inspections (USFDA, WHO, MHRA), and Regulatory preparation. Skilled in process validation, equipment qualification, line clearance, and environmental monitoring to ensure consistent product quality. Adept at coordinating across departments for timely product release, responding to regulatory queries, and maintaining data integrity throughout QA/RA operations. Familiar with CTD/eCTD formats, risk assessment, PQR/APQR preparation, and regulatory submissions including variations and renewals. Handling Of Applications Like CMS,QAMS, FMEA. Lead in the implementation of assurances process controls, and CAPA systems designed to meet or exceed internal and external requirements.
Overview
6
6
years of professional experience
1
1
Certification
Work History
Quality Assurance (Batch Record) Engineer (QA)
Snap Code Inc
04.2023 - Current
- Develop and maintain standardized procedures for reviewing batch records to ensure compliance with regulatory requirements and company standards.
- Implements improvements in batch record management systems, resulting in a 20% reduction in errors and discrepancies.
- Participate in regulatory inspections and customer audits, provide comprehensive documentation and support for batch record review processes.
- Trainee personnel on batch record documentation practices and compliance with Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP).
- Support audit and inspection preparation, resolution of audit and inspection findings and liaised with auditing groups and inspectors through all stages of the audits.
- Coordinate Line clearances, Shift changes activities.
- Actively manage deviations to achieve RFT (right first time), ensuring smooth transition of the defined actions and CAPAs to applicable stakeholders for on-time completion and closure.
- Collaborate with manufacturing to help identify root cause, corrections in case of non-conformance.
- Promote the change control process, risk management tools and CAPA process as prevention drivers in manufacturing activities.
- Utilize electronic document management systems (EDMS) for efficient storage, retrieval, and management of batch records and related documentation.
Quality Assurance (QA) and Regulatory Affairs (RA) Specialist
Divis Laboratories Limited
Hyderabad, India
09.2021 - 07.2023
- Responsible for the development and maintenance of quality programs, systems, processes, and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
- Supported audit and inspection preparation, resolution of audit and inspection findings and liaised with auditing groups and inspectors through all stages of the audits.
- Identified opportunities for Quality continuous improvement of manufacturing practices based on a risk approach.
- Collaborated with Engineering and RA to support product / line changes, ensure compliance aspects associated to validation and risk management activities.
- Actively managed deviations to achieve RFT (right first time), ensuring smooth transition of the defined actions and CAPAs to applicable stakeholders for on-time completion and closure.
- Provided quality oversight for area-specific change controls, deviations, and CAPAs and participated in/and reviewed investigations.
- Collaborated with manufacturing to help identify root cause, corrections in case of non-conformance.
- Promoted the change control process, risk management tools and CAPA process as prevention drivers in manufacturing activities.
- Assisted with internal quality audits and coordinated training on Quality concepts and systems for preparation of sitewide Regulatory Inspection activities and responses.
- Facilitated training as SME on Quality-focused systems/projects assisting with the remediation of compliance risks.
- Prepared reports and necessary documentation (Corrective and Preventative Actions) and provided to applicable stakeholders, both internal and external.
- Initiated, reviewed and updated the Quality Manual and Standard Operating Procedures and Change Control implementation processes in QAMS.
- Developed, implemented, and provided recommendations of Quality Management Systems documents such as Standard Operating Procedures per Quality policies and procedures per local regulatory requirements.
- Responsible for maintaining and tracking quality systems documentation and requests in accordance with regulatory requirements and internal processes.
- Maintenance of quality systems and cGMP compliance for the business by ensuring that all team members comply with processes, procedures and instructions for all activities in which the team participates.
Quality Assurance Engineer (QA)
V Tek Systems Inc
07.2022 - 04.2023
- Ensured compliance with cGMP, GLP, and ICH guidelines in manufacturing and documentation of solid oral dosage forms.
- Conducted line clearance and in-process checks during manufacturing and packaging operations.
- Prepared and reviewed Batch Manufacturing Records (BMRs) and Batch Packaging Records (BPRs) for accuracy and completeness.
- Executed and reviewed Deviation Reports, Change Controls, CAPA, and Out of Specification (OOS) investigations.
- Assisted in internal audits, vendor audits, and external regulatory inspections (e.g., USFDA, WHO, MHRA).
- Monitored environmental conditions in production and sampling areas to maintain product quality.
- Supported preparation of regulatory dossiers (CTD/eCTD formats) for product registration in semi-regulated and regulated markets.
- Reviewed and maintained SOPs, protocols, and reports related to QA and RA activities.
- Conducted market complaint investigations and initiated appropriate corrective/preventive actions.
- Maintained and updated Product Quality Reviews (PQRs) for solid dosage products.
- Ensured data integrity compliance across production, quality control, and documentation practices.
- Participated in risk assessment and mitigation for quality-impacting activities.
- Reviewed and compiled Regulatory Submission Documents including drug master files, site master files, and product dossiers.
- Trained junior staff and operators on quality standards, SOPs, and documentation procedures.
- Participated in technology transfer and validation activities, including process validation, cleaning validation, and equipment qualification.
- Handled label control activities, ensuring accurate issuance, reconciliation, and disposal as per SOPs.
- Assisted in preparing Annual Product Quality Reviews (APQRs) for continuous product quality monitoring and regulatory compliance.
- Actively contributed to deviation investigations and root cause analysis, supporting timely closure and implementation of Corrective and Preventive Actions (CAPAs).
- Ensured timely submission of regulatory queries/responses to regulatory authorities and business partners.
- Maintained document control systems, ensuring version control and archival of quality documents.
- Supported the RA team in compiling and submitting Variations and Renewals as per local and international regulations.
- Contributed to the development and revision of Risk Management Plans (RMPs) and Quality Risk Assessments (QRA).
Quality Assurance Specialist
Divis Laboratories Limited
Hyderabad, India
09.2020 - 08.2021
- Responsible for the management of QA documentation (Document Change Requests and Approvals, Quality Record Retention, Batch Record Issuance).
- Ensured timely issuance of production records, procedures and labels and performed timely assessment and closure of discrepancies, Deviations and Change Controls requests.
- Responsible for assessment and closure of Laboratory Investigations, batch and material hold events.
- Supported the development and maintenance of key aspects in Quality Systems, designed to meet the minimum regulatory and Quality requirements to assure compliance with FDA Quality Systems Regulations and ISO requirements.
- Supported and Conducted Quality investigations using Track Wise system to ensure timely implementation of corrective actions and preventive actions (CAPAs) in compliance with the cGMP specific standards and Training of Employees In Competancy Management Systems (CMS).
- Responsible for appropriate and effective corrective and preventive (CAPA) actions and CAPA coordination throughout the company’s quality system in response to pertinent observations from the audit program, external regulatory agency inspections, complaints and other procedural/product non-conformances.
- Responsible for document Control activities through the electronic documentation system, including training associates to read, review and approve documents; and maintaining a fully compliant system.
- Performed detailed document review to perform product release activities.
- Performed quality warehouse functions such as periodic review of activities, process monitoring, procedure review, assistance with process improvements, act as training liaison, assist in the development of an appropriate incoming product receipt process.
- Assisted with internal audits and supplier audits as required to support the Quality System.
- Assisted in the gathering, trending and reporting of metrics that effectively measure and communicate quality performance.
- Reported trends in Deviation and CAPA records to monitor performance for continuous improvement.
- Identified and created trend analysis for key quality performance indicators and NC/CAPA effectiveness monitoring.
Education
Bachelor of Pharmacy - undefined
Chebrolu Hanumaiah institute of pharmaceutical Sciences
IndiaMaster's - health care management
St. Francis's College
Brooklyn, NY05.2025
Skills
Critical thinking
Project management
Project planning
Data analysis
Root-cause analysis
Quality control
Time management
Quality assurance controls
Technical writing
Manufacturing processes
Failure analysis
Content management systems (CMS)
Budget management
Quality assurance
Certification
Texas State Board Of Pharmacy Trainee Technician License (MAR 2026 - MAR 2028)
Timeline
Quality Assurance (Batch Record) Engineer (QA)
Snap Code Inc
04.2023 - Current
Quality Assurance Engineer (QA)
V Tek Systems Inc
07.2022 - 04.2023
Quality Assurance (QA) and Regulatory Affairs (RA) Specialist
Divis Laboratories Limited
09.2021 - 07.2023
Quality Assurance Specialist
Divis Laboratories Limited
09.2020 - 08.2021
Bachelor of Pharmacy - undefined
Chebrolu Hanumaiah institute of pharmaceutical Sciences
Master's - health care management
St. Francis's College