Indirajith Rajendran

About Indirajith Rajendran

I am a proactive and achievement-driven Quality professional with 15+ years of experience in managing and strengthening end-to-end Quality Management Systems within the pharmaceutical industry. I specialize in implementing global quality standards to enhance product quality, streamline deviations, change control, CAPA, OOS, and failure investigations, while effectively monitoring performance and leading process improvement initiatives.With a forward-thinking mindset, I have strong expertise in planning and executing comprehensive audits of pharmaceutical manufacturing facilities to assess compliance with GMP, FDA regulations, and other applicable quality standards. I am skilled in evaluating processes, identifying gaps, and ensuring alignment with regulatory expectations.My core strengths include a deep understanding of manufacturing processes, systems, and documentation, combined with the ability to identify improvement opportunities and recommend practical, sustainable solutions that enhance overall quality, compliance, and operational efficiency.

Experience

1. Compliance Manager

   Biocon Biologics

   Feb 2026 — Present

Education

• Bharathiar University

  Bachelor's Degree, Biochemistry

  2003 — 2006

• Bharathiar University

  Master's Degree, Biochemistry

  2006 — 2008

Skills

• Root Cause Analysis
• Quality Management
• Process Validation
• Annual Reports
• Administration
• Deviation Management
• Employee Training
• Cleaning Validation
• Production Planning
• Cgmp Manufacturing
• Process Improvement
• Change Control
• Environmental Management Systems
• Personnel Management
• Capa
• Equipment Qualification
• Investigation