Shailesh G.

About Shailesh G.

I have a Master’s degree in Regulatory Affairs with a focus on Quality Assurance and…

Experience

1. Quality Assurance Associate

   Medivant Healthcare

   Feb 2025 — Present · Phoenix, AZ, US

   Maintain and manage documentation in compliance with Good Documentation Practices (GDPs), FDA 21 CFR Part 211, and cGMP requirements to ensure regulatory readiness. • Conduct Acceptance Quality Limit (AQL) inspections and perform line clearances to verify product quality and prevent cross-contamination. • Develop and maintain Master Batch Records (MBRs), Process Validation, Stability, and Hold Time. Protocols following ICH Q8, Q9, and Q10 guidelines to ensure regulatory compliance. • Identify root causes of quality deviations and contribute to Corrective and Preventive Actions (CAPA) to maintain compliance with regulatory expectations. • Verify label accuracy, serialization compliance, and packaging integrity per FDAs 21 CFR Part 211.122 and global regulatory standards to prevent labeling errors. • Oversee destruction of non-compliant products, raw materials, and controlled substances in adherence to FDA, EPA, and DEA regulations to maintain quality and safety standards.