James Martin
About James Martin
James Martin is an Operations Manager and Computer Systems Validation Subject Matter Expert at Azzur Group, with extensive experience in regulatory compliance and quality assurance in the life sciences industry. He has held various positions in companies such as Sepracor, AG Mednet, and QinetiQ North America, and has a strong educational background in Engineering Technology and Business Administration.
Current Role at Azzur Group
James Martin serves as the Operations Manager and Computer Systems Validation (CSV) Subject Matter Expert (SME) at Azzur Group. He has held this position since 2019 in Cary, North Carolina. In this role, he focuses on ensuring compliance with various regulations and standards while overseeing operations related to computer systems validation.
Previous Experience in Quality Assurance
Before joining Azzur Group, James Martin worked at AG Mednet as the Senior Manager of Quality Assurance and Regulatory Compliance from 2009 to 2019. He also held the position of Pharmaceutical QA Manager and Design Engineer at QinetiQ North America from 2002 to 2006. His background includes extensive experience in compliance assurance across multiple regulatory frameworks.
Educational Background
James Martin studied Engineering Technology at Wentworth Institute of Technology, where he earned an Associate of Science degree. He also attended Framingham State University, achieving a degree in Marketing Management and Business Administration. Additionally, he completed certification courses in Fire and EMS at Johnston Community College.
Expertise in Regulatory Compliance
James Martin possesses extensive knowledge of compliance with a variety of agency and industry regulations, including 21 CFR Parts 11, 50, 58, 203, 210, 211, 312, 314, 820, as well as ISO9000, AS9100, HIPAA, and GDPR standards. He specializes in leading validation strategies within the life sciences sector, ensuring timely execution of validation deliverables.
Validation and Quality Management Skills
James Martin is proficient in Good Automated Manufacturing Processes (GAMP5) and has a comprehensive understanding of agency guidance documents related to computerized systems and pharmaceutical cGMPs. His skills include supporting product/application processes, QMS documentation, training, and conducting internal and external audits.