Sunil Patil

About Sunil Patil

With over a decade of experience in quality control, I currently contribute to RPG Life…

Experience

1. Senior Manager Quality Control

   RPG Life Sciences Ltd.

   Sep 2024 — Present

   Leadership & Team Management: Leading the planning & allocation of daily work to subordinates of quality control department and ensuring timely releases & approvals of RM, PM, In-process, FP Samples. Lead, mentor, and develop the QC team, fostering a culture of quality, collaboration, and innovation. Oversenie team performance, provide training on new QC methodologies and technologies, and conduct regular performance reviews. Coordinate with the QA department to align QC and QA processes, ensuring seamless quality compliance across production. Quality Control & Assurance Operations: Manage all QC activities, including raw material, in-process, and finished product testing, ensuring compliance with regulatory and internal quality standards. Implement advanced analytical techniques (e.g, HPLC, GC, FTIR, UV-VIS) for precise quality assessments. Support Quality Assurance initiatives, including CAPA (Corrective and Preventive Actions), change control, deviations management, and risk assessments. Oversee data integrity and automation in QC labs, ensuring compliance with 21 CFR Part 11 and other digital standards. Regulatory Compliance & Audits: Ensure adherence to CGMP, GLP, FDA, EMA, BP, USP, and other regulatory guidelines. Prepare and lead regulatory inspections and audits (USFDA, EU GMP, WHO-GMP, MHRA, etc.) with minimal observations. Address and resolve audit findings with effective corrective actions. Advanced Technology & Process Improvement Introduce and implement new QC technologies, automation tools, and digital transformation initiatives (e.g, E logbook, LIMS, SAP, and QbD approaches). Enhance efficiency and cost-effectiveness through continuous improvement initiatives. Collaborate with IT and QA to integrate electronic documentation, real-time monitoring, and predictive analytics into QC workflows. Documentation & Reporting

Education

• Kuvempu University

  M.Sc, Chemistry

  2008 — 2010