Senior Executive - Quality Assurance

About the role

Responsible for planning, coordinating, and executing vendor qualification and requalification activities in compliance with cGMP, regulatory requirements, and applicable company procedures. The role includes assessment of new and existing vendors, review of vendor qualification documents, coordination of vendor audits, evaluation of audit observations and CAPA responses, and preparation/review of vendor assessment reports.

What you'll do

• Evaluate vendors for raw materials, starting materials, intermediates, packaging materials, and other critical services , as applicable
• Prepare and maintain Vendor evaluation Reports, CAPA tracking, and related quality documentation
• Conduct risk-based vendor assessments in accordance with applicable SOPs, ICH guidelines, and regulatory expectations
• Monitor vendor performance through quality trends, deviations, OOS/OOT, complaints, change notifications, and other relevant quality indicators
• Ensure all activities are performed in compliance with cGMP, ICH guidelines, applicable regulatory requirements, and company Quality Management System

What you need

• GMP
• SOP writing
• Regulatory affairs
• Any graduate