Kotha Chakradhar
Regulatory Affairs/Formulation Research and Development/Quality Assurance. Regulatory Intern l Formulation scientist @ Long Island University
- Role
- Quality Assurance and Regulatory Affairs Specialist at Hhh Pharmaceuticals
- Location
- Jersey City, NJ, US
- LinkedIn followers
- 500 followers
About Kotha Chakradhar
Currently pursued a Master\'s degree in Drug Regulatory Affairs at Long Island University…
Experience
Quality Assurance and Regulatory Affairs Specialist
Jun 2025 — Present · Rahway, NJ, US
Performed line clearance before each manufacturing and packaging stage to ensure area and equipment readiness. Monitored in-process quality checks during granulation, compression, encapsulation, blending, and powder filling. Verified critical parameters like tablet weight, hardness, friability, disintegration time, and capsule fill weight. Conducted sampling for blend uniformity, LOD, and other key quality attributes. Reviewed Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR) in real-time for accuracy and compliance. Identified, documented, and supported investigations for deviations, non-conformances, and product defects. Ensured compliance with GMP, SOPs, and regulatory guidelines (21 CFR Part 210/211, ICH Q8–Q10). Monitored environmental conditions, operator hygiene, and gowning practices during production. Verified packaging materials, batch coding, labeling accuracy, and ensured correct product-label matching. Supported label reconciliation, tamper-evidence verification, and packaging integrity checks. Participated in change control, risk assessments, and implementation of CAPA. Ensured data integrity by maintaining real-time and accurate documentation (ALCOA+ principles). Supported training initiatives and maintained audit readiness for regulatory inspections (FDA, MHRA, WHO, etc.
Education
Long Island University
Master's degree, Drug regulatory affairs
BAPATLA COLLEGE OF PHARMACY, BAPATLA-522101(CC-10)
Bachelor of Pharmacy - BPharm, Pharmacy
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