Viraj Kareka

Digital Validation SME & Associate Director C&Q

MMR Consulting

Viraj has over 17 years of combined pharma / biotech experience in CQV, compliance, and manufacturing. He is a Kneat power user Level 2, a Kneat-certified master trainer, and is trained in ValGenesis. He is a practical industry SME and leader, with experience as both an end user and a consultant. His core specialties include lean “outside the box” risk-based digital C&Q approaches, with planning and implementation of large / complex C&Q projects. Viraj has led major greenfield & brownfield CQV projects which have won ISPE awards, using risk-based approaches. He has also implemented Paperless Validation successfully at multiple companies and has used Paperless Validation across multiple projects.