Charis Jervah Email & Phone Number

United States

Andrx/Watson Laboratories/Allergan/Actavis (Acquired by Teva) | Change ManagementStarted as a Change Control Coordinator and progressed through multiple company acquisitions. • Change Management Dept. Lead, supporting all operational functions across two sites. Key contact for Business Partner change management activities.• Directed the implementation of TrackWise Harmony quality system, moving the site from paper-based to a validated electronic system.• TrackWise Division Leader responsible for training employees at all levels to gain system access.• Authored, reviewed, and approved change control records, including those having impact on regulatory filings. • Facilitated weekly Change Control Board meetings (created agenda / distributed minutes).• Performed Metrics reporting to support monthly Quality Council.• Enforced quality throughout reviews, including adherence to Good Documentation Practices (GMP). • Maintained the Electronic Documentation Management System (eDMS) and managed several system implementations.• Five+ years of experience of managing people in a GMP environment.• Managed and supported backroom for FDA and Business Partner audits / inspections.• Supported the Change Control Site Master Plan initiative for simplification and streamlining. • Support CAPAs/Deviations ensuring on time closure• Completed OPEX White Belt training projects• Improved the Change Control process and supported initiators on the closure requirements to change Site Quality Metric from Red to Green • Implemented the Change Control Board• Implemented a Tracking System (Trackwise) for Method and Process Changes