Managing Consultant
CurrentPerformed numerous validation compliance audits to assess systems against current regulatory expectations along with company compliance policies. Reviewed and assessed complete validation documentation, standard operating procedures and organizational policies to document the gaps in processes and validation effort. Recommended policy change, procedure revisions and, additional testing to bring the systems into regulatory & corporate complianceManaged site wide computer system validation compliance project for major global pharmaceutical client with a diverse senior management project team. Project entailed remediation of Laboratory and Manufacturing Equipment Computer Systems, Building Automation Systems, and 21 CFR Part 11. The Project also included harmonization of site procedures in Computer System Validation, Change Control, 21 CFR Part 11 Policy, & IT infrastructure. Responsibilities included to Documentation Preparation & Review and Project Planning & Updates.