Madeleine Shannon

Sr Consultant i @Project Farma Pf

Gaithersburg, MD, US

Drafted and reviewed a wide range of validation documents, including User Requirements Specifications, System Impact Assessments, Data Integrity Assessments, Configuration Specifications, Validation Plans, Standard Operating Procedures, Commissioning protocols, Installation, Operational, and Performance Qualification protocols, Validation Summary Reports, and associated forms. Executed commissioning and qualification protocols in accordance with accordance with requirements established in the Validation Master Plan (VMP) and Good Documentation Practices (GDP), including the following: Utilities, Building Monitoring System, Engineering Drawing Management System, Computerized Maintenance Management System, Kaye AVS and ValProbe system, Controlled Temperature Units, Automated Cell Counters, Automate Hematology Analyzer, Spectrophotometer, Controlled Rate Freezers, PCR Thermal Cycler, Cell Wash & Concentrate System, and a cloud-based building security system. Generated and maintained schedule for CQV workstream.Facilitated and fostered collaboration between Facilities, Validation, Manufacturing, Quality Control, and Quality Assurance to ensure business needs were met within required timeline.