George Grigonis, Jr.
Consultant

George J. Grigonis, Jr. is a systems quality assurance and systems validation professional with 21 years of experience in pharmaceutical industry process validation and computer validation methods for both regulated and non-regulated environments. Formerly, Grigonis was affiliated with Merck & Co., Inc. as manager and consultant in information services. He was principally responsible for quality assurance and validation practices for the company’s computing environments and managed the corporate and divisional programs for supplier evaluation and management in the procurement of automation products and services. He has held senior consultant positions in several consulting firms providing services for computer validation and electronic records management.  

Grigonis has served on various industry committees and task groups for computer validation, compliance and electronic records. He was the lead architect for the PDA’s Supplier Auditing and Qualification Task Group that resulted in the TR-32 Program and was the principal investigator that resulted in PDA’s Task Group on Part 11 and the GERM guidance for electronic records management.