BINDU HASINI KAKURU
Jersey City,NJ
Summary
Detail-oriented Quality Assurance and Regulatory Affairs professional with a master's degree in Drug Regulatory Affairs and experience supporting quality systems in regulated pharmaceutical and clinical environments. Skilled in documentation review, audit support, data verification, and compliance with GLP, GCP, GDP, and cGMP regulations. Experienced in reviewing records for accuracy, supporting inspections, maintaining regulatory documentation, and ensuring adherence to SOPs and regulatory standards. Strong attention to detail, organizational skills, and ability to work independently and collaboratively in quality-focused environments.
Overview
1
1
year of professional experience
1
1
Certification
Work History
Quality Assurance Intern
Darwin Pharmaceuticals Pvt. Ltd.
India
07.2022 - 03.2023
- Supported Quality Assurance operations in a regulated pharmaceutical environment, ensuring compliance with cGMP and internal SOPs.
- Reviewed Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR) for accuracy, completeness, and compliance with Good Documentation Practices (GDP).
- Verified line clearance activities before production to ensure proper documentation and compliance with quality standards.
- Assisted in deviation investigations, CAPA tracking, and change control documentation.
- Maintained controlled documents including SOP review, version control, issuance, and archival.
- Organized quality documentation and supported audit readiness activities for internal and external inspections.
- Maintained equipment calibration and qualification documentation to ensure regulatory compliance.
- Collaborated with QA, QC, and production teams to address quality issues and maintain compliance with regulatory expectations.
Clinical and Quality Assurance Intern
Manipal Hospital
India
02.2022 - 06.2022
- Conducted quality assurance review of patient records and clinical documentation to ensure accuracy, completeness, and compliance with GCP and hospital SOPs.
- Maintained audit-ready clinical files supporting internal and external inspections.
- Verified case report forms, patient documentation, and study records for data integrity and consistency.
- Identified documentation gaps and deviations, and assisted in implementing corrective actions.
- Collaborated with clinical and administrative teams to ensure adherence to QA standards.
- Participated in QA training sessions on Good Documentation Practices, GCP compliance, and inspection readiness.
Clinical Research / QA Intern
Sajala Bio Labs Pvt. Ltd.
India
09.2021 - 11.2021
- Maintained quality oversight of clinical study documentation in compliance with GCP, GLP, and FDA requirements.
- Performed audit and inspection readiness activities, including review of study protocols, case report forms, and regulatory files.
- Verified data accuracy and completeness across clinical study records and reports.
- Assisted in identifying potential compliance gaps and implementing corrective actions.
- Supported document control, record maintenance, and version management to ensure regulatory compliance.
- Collaborated with clinical teams to ensure study conduct aligned with QA standards and SOPs.
Education
Master of Science - Drug Regulatory Affairs
Long Island University
Brooklyn, NY06.2025
Bachelor of Pharmacy - undefined
K L University
Andhra Pradesh, India05.2022
Skills
Quality & Compliance
GLP, GCP, cGMP, GDP
FDA & ICH Regulatory Guidelines
Documentation Review & Data Verification
SOP Management & Document Control
Deviations, CAPA & Change Control
Audit Support & Inspection Readiness
Quality Records Management
Good Documentation Practices (GDP)
Microsoft Excel, Microsoft Word, PowerPoint
Base SAS (Certified)
Certification
- Base SAS Certification
- Clinical Data Management
- Regulatory Affairs (Course-based)
Timeline
Quality Assurance Intern
Darwin Pharmaceuticals Pvt. Ltd.
07.2022 - 03.2023
Clinical and Quality Assurance Intern
Manipal Hospital
02.2022 - 06.2022
Clinical Research / QA Intern
Sajala Bio Labs Pvt. Ltd.
09.2021 - 11.2021
Master of Science - Drug Regulatory Affairs
Long Island University
Bachelor of Pharmacy - undefined
K L University