Jagadeesh Velivela

About Jagadeesh Velivela

Quality Engineer with 4+ years of experience in the Medical Device Industry supporting…

Experience

1. Quality Engineer

   Nevakar Pharmaceuticals

   Jun 2024 — Present · NJ, US

   Provided quality assurance support for pharmaceutical products, medical devices, biologics, and combination products, ensuring compliance from raw material inspection to final product shipment.• Reviewed Process Qualification (PPQ) activities, focusing on process controls, raw material controls, and validation documentation.• Collaborated cross-functionally with R&D, MS & T, Supply Chain, and Regulatory Affairs to support design control, new product introduction, and design changes for medical and combination products.• Supported regulatory and internal audits (e.g, FDA, EMA,), preparing and presenting quality data, and ensuring alignment with global regulatory requirements.• Maintained and enhanced quality systems in accordance with corporate policies, SOPs, and regulatory guidelines for drug, biologics, and device compliance.• Conducted gap assessments and implemented CAPA strategies to drive continuous improvement and mitigate quality risks.• Coordinated and delivered training programs on quality systems and regulatory compliance across departments and affiliates.• Supported supplier and incoming quality assurance functions, including material qualification and compendia management.