James Martin

Operations Manager Computer Systems Validation (Csv) Subject Matter Expert (Sme) @Azzur Group

As the Operations Manager for the Raleigh, NC office I work with our management team to assure business processes are in place and are properly utilized. As a Computer Systems Validation (CSV) Subject Matter Expert (SME)/ Project Manager I work with clients to plan, implement and monitor their validation strategies in the highly regulated life sciences industry. I assure Validation deliverables are executed on-time and provide status reports to Senior Management. I prepare protocols and summary reports demonstrating to regulators that the intended use of the system has been properly verified and documented. I have worked with engineering groups fully validating systems in a development environment as well as on teams performing qualifications on instrumentation and applications. I have experience with audits, corrective actions, disaster recovery, data integrity, training, process and writing SOPs and general QMS activities.