Navatha Reddy

Lexington,KY

Summary

Quality Assurance and Quality Control professional with 2 years of combined experience in pharmaceutical and regulated environments, including 1 year in QA and 1 year in QC within cGMP-compliant operations. Experienced in in-process QA support, batch record review, environmental monitoring concepts, deviation investigations, CAPA management, and analytical testing of raw materials and finished products. Proficient in compendial methods (USP/EP/JP), root cause analysis, and maintaining data integrity (ALCOA+). Adept at supporting manufacturing operations, laboratory testing, audit readiness, and cross-functional collaboration to ensure product quality and regulatory compliance.

Overview

years of professional experience

Work History

Quality Control Analyst

Catalent Pharma Solutions

Winchester, KY

03.2025 - Current

- Perform routine and non-routine analytical testing of raw materials, APIs, finished products, and stability samples in compliance with USP, EP, JP, and cGMP requirements
- Execute analytical techniques including HPLC, GC, FTIR, UV-Vis, Dissolution, Karl Fischer, and Titration
- Prepare and label reagents, standards, and solutions according to SOPs
- Participate in OOS/OOT investigations and support root cause analysis
- Maintain accurate laboratory documentation in compliance with GDP and ALCOA+ data integrity principles
- Support batch release activities by interpreting and reporting analytical results
- Perform instrument calibration, troubleshooting, and maintenance
- Conduct peer review of analytical data and documentation
- Assist with cleaning verification testing and stability sample testing
- Support material sampling activities and laboratory inventory management
- Collaborate with cross-functional teams to resolve analytical and quality-related issues

Quality Assurance Specialist

Zensoft

India

02.2024 - 02.2025

- Performed in-process QA activities supporting manufacturing operations and ensuring adherence to SOPs and cGMP requirements
- Reviewed executed batch records and protocols to support timely and compliant batch disposition
- Supported line clearance activities including inspection, labeling, and packaging compliance
- Conducted deviation investigations and CAPA management including root cause analysis and impact assessment
- Participated in GMP investigations including risk assessments and documentation of findings
- Assisted in maintaining quality systems documentation including SOPs, reports, and technical documents
- Supported audit readiness activities and participated in internal and external audits
- Maintained compliance with cleanroom behavior and aseptic practices
- Assisted in tracking quality metrics and trend data for process improvements
- Collaborated with cross-functional teams to ensure regulatory and site compliance
- Adhered to health, safety, and environmental compliance requirements

Education

MS - Regulatory Affairs

Northeastern University

Boston, MA

Doctor of Pharmacy (Pharm.D) - undefined

Andhra University