Team Member Qualifications

About the role

This role is for a Qualification & Validation Specialist responsible for executing equipment and system qualification protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). The position involves coordinating with vendors and cross-functional teams, preparing risk assessments, SOPs, validation programs, and master plans, and ensuring compliance with cGMP standards.

What you'll do

• Be responsible for executing qualification protocols (IQ, OQ, PQ), coordinating with vendors and cross-functional teams
• Be responsible for compiling qualification documents, preparing risk assessments, SOPs, validation programs, and master plans
• Be responsible for executing equipment requalification as per schedule and updating qualification schedules
• Be responsible for assisting in audit responses, coordinating with QA for CAPA, incidents, deviations, and audit reports
• Be responsible for preparing master documents (SOPs, operating instructions, VMPs) and coordinating risk assessments for equipment/systems

What you need

• 8–10 yrs of experience
• GMP
• Documentation
• Calibration
• Preventive maintenance
• Lean
• SOP writing
• B.Tech or B.E.