Sumed W.

About Sumed W.

Dynamic Specialist in Quality Operations with over 10 years of experience in…

Experience

1. Specialist Quality Operations

   Novartis

   Oct 2023 — Present · Hyderabad, IN

   Manage various types of Change control including Product stewardship, Administration stewardship, Asset stewardship within the 1QEM system from change initiation to closure.• Collaborate with Quality and Operations teams to identify compliance gaps and ensure adherence to regulatory standards.• Generate and analyse predetermined and ad-hoc reports using various applications, promptly performing follow-up actions as necessary.• Comply with internal requirements including KPI reporting and ticket management tools, alongside other procedures and processes.• Assist the department with additional ad-hoc activities or requests to meet organisational objectives.• Demonstrate accountability and ownership of the assigned tasks and responsibility.• Monitor and govern the Change process, ensuring adherence, performance and quality through detailed reporting and analysis.• Schedule the governance and CRB meetings, identifying opportunities for optimisation within Change control and Release management processes.• Provide onsite or remote support as necessary, focusing on the timely completion of assigned tasks and training requirements.• Actively support internal and external audits by gathering and presenting the requested process data and reports.• Contribute to critical issue resolution by providing expert quality advice and direction to stakeholders.• Ensure compliance with current GxP and internal policies, delivering quality operations services to support product quality compliance and regulatory workflows.• Escalate service related GxP and Non-GxP issues and ensuring timely investigation and adherence tolocal and global operating procedures.