Karthikeya KMT

Pharmaceutical professional with over 23 year of experience in Quality and Technical operations having expertise in development & deployment of Quality Management Systems (QMS), Commissioning, Qualification & Validation (CQV) strategies and Data Integrity (DI) Controls for GMP operations of different dosage forms in globally renowned leading pharmaceutical Companies catering products across the globe like; Wyeth (Pfizer), Johnson & Johnson, Sandoz, A Novartis company and Akorn Pharmaceuticals and Aurobindo Pharmaceutical. Currently engaged with GxPFONT Consulting Group, a global Pharma Consulting and Technology solutions company, as Director – Quality Systems. Played significant leadership role in establishing governance structure to manage Technical (GMP), Quality & Compliance activities of operations. Played crucial role in bringing organizations out of data integrity and GMP deficient issues via identifying and managing the implementation of effective CAPA’s via engineering or procedural controls. Engaged in assessment and certification of CMO’s, CRO’s, Raw material manufacturing companies and service provider’s qualification program. An active member of ECA Visual Inspection working group.