Team Member Qualifications
VisakhapatnamFull-time8–10 yrsPosted 1 week ago
Senior pharma role at Dr Reddy's Laboratories in Visakhapatnam. Needs 8–10 years and a B.Tech or B.E..
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
- GMP
- Documentation
- Calibration
- Preventive maintenance
- Lean
- SOP writing