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Kathiresan Subramanian

Senior Consultant, Global Pharma Biotech

Kathir Subramanian has over 27 years of experience in various capacities, including senior roles with increasing responsibilities and leadership positions in which he has provided strategic direction and viable solutions and cultivated opportunities for expansion and growth in pharmaceutical industries. He has worked with Pfizer; Hibrow; Endo (Legacy Par, NuRay, Actavis); Piramal; NuRay in India; Schneider Electric (Legacy Invensys Process System), U.S.; and Merck (Legacy Schering-Plough), Singapore. He has held positions as general manager of corporate QA, head of quality assurance, head of quality, head of compliance, compliance solutions consultant and quality specialist.

Areas of Expertise:

  • Consulting for various clients in the areas of quality in accordance with ICH Q2, Q3, Q7, Q8, Q9, Q10, U.S. FDA and EU GMP requirements
  • Optimizing QMS effectiveness and sustainable compliance
  • Specializing in implementation of structured DMAIC investigation strategy to reduce reoccurrence
  • Facilitating and executing on-site validation (facility, utilities, equipment, laboratory instrument, computer system, process and cleaning)

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