Haritha Cherukuru
Hampton
Summary
Driven Quality Assurance Associate with a Master’s in Pharmacology and Toxicology, specializing in regulatory compliance, risk management, and process optimization. Expertise in GMP, FDA, and ISO standards, ensuring consistent product quality. Adept at using analytical skills to improve processes and support continuous improvement in pharmaceutical environments.
Overview
5
5
years of professional experience
1
1
Certification
Work History
Quality Assurance Associate
Ingenus Pharmaceuticals LLC/ Ricon Pharma, LLC.
05.2024 - Current
- Ensured compliance with GMP, GLP, ICH guidelines, and regulatory requirements for generic drug development.
- Reviewed and validated bioequivalence (BA/BE) and pharmacokinetic study data to ensure therapeutic equivalence.
- Assisted in the preparation and review of analytical method validation, stability studies, and safety profiles of drug products.
- Reviewed risk assessments for impurities, excipients, and degradation products under ICH M7 and Q3A/Q3B guidelines.
- Monitored deviations, OOS results, CAPA implementation, and documentation of genotoxicity and carcinogenicity studies to maintain quality standards.
- Collaborated with development, manufacturing, and testing teams to ensure data integrity, regulatory compliance (FDA, ICH, USP), and post-marketing safety.
Quality Assurance Supervisor
Divis Laboratories Limited
09.2019 - 07.2022
- Managed QA aspects of cGMP manufacturing project by acting as QA Representative and worked on issues critical to quality
- Reviewed and approved Quality Management System (QMS) documents related to multiple projects, including SOPs, Material and Product Specifications, Master Production Records, Validation Protocols, Reports and Change Controls
- Prepared reports and necessary documentation (Corrective and Preventative Actions) and provided to applicable stakeholders, both internal and external
- Initiated, reviewed, and updated Quality Manual and Standard Operating Procedures and Change Control implementation processes
Education
Master's - Pharmacology and Toxicology
Wright State University
04.2024
Bachelor of Pharmacy - Pharmacy
Chebrolu Hanumaiah Institute of Pharmaceutical Sciences
04.2019
Skills
- Quality Management Systems
- Deadline Adherence
- Cross-Functional Team Collaboration
- Issue Resolution
- Product Quality Assessment
- Corrective Action Strategy Development
- Process Documentation
- Quality Control Oversight
- ISO Compliance Knowledge
- Audit Process Management
- Validation techniques
Certification
- Certified in Responsible Conduct of Research.
- Certified in Initial Biosafety Training.
- Certified in Good Clinical Practices.
- Certified in Biomedical Research Investigation
- Certified in Human Subjects Research
Project & Publication
Formulation and Pharmacodynamic Evaluation Of Quetiapine Solid Dispersions using Plasdone K-29/32 as Carrier, Published review article entitled “Formulation and Pharmacodynamic Evaluation Of Quetiapine Solid Dispersions using Plasdone K-29/32 as Carrier” in Research Journal of Pharmacy and Technology, 2020.
DOI: 10.5958/0974-360X.2020.00424.2
Timeline
Quality Assurance Associate
Ingenus Pharmaceuticals LLC/ Ricon Pharma, LLC.
05.2024 - Current
Quality Assurance Supervisor
Divis Laboratories Limited
09.2019 - 07.2022
Bachelor of Pharmacy - Pharmacy
Chebrolu Hanumaiah Institute of Pharmaceutical Sciences
- Certified in Responsible Conduct of Research.
- Certified in Initial Biosafety Training.
- Certified in Good Clinical Practices.
- Certified in Biomedical Research Investigation
- Certified in Human Subjects Research
Master's - Pharmacology and Toxicology
Wright State University
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