Lillian Go

About Lillian Go

Quality professional with 25 years of experience in Pharmaceutical, Biotechnology, and…

Experience

1. Sr Document Control Specialist

   BrioHealth Solutions

   Mar 2021 — Present

   Manage the Document Change Order (DCO) process for the release, approval, distribution, maintenance, retrieval, and storage of quality system documents. • Maintain and update the Master Document List and Document Change Control Logs to ensure consistency and record keeping. • Support DCO requests from cradle to grave • Report metrics to management on Change Order status, barriers, roadblocks and work with the team to overcome challenges in document review/approval process • Support compliance to the personnel training program and maintain the training matrix by working with hiring managers to ensure current training records are compliant with Standard Operating Procedures • Follow up with managers regarding overdue training and or missing records • Support and maintain Design History Files, Regulatory Technical files, Device Master Records, and other Design Dossier documents. • Assist with internal audits in compliance with the company’s internal audit procedure. • Maintain the quality systems database for the purpose of providing quality metrics data on routine basis or as required. • Support the Quality and Regulatory departments during product development projects to ensure compliance to regulatory requirements throughout the development process • Review and correct errors in documents as needed • Support complex Class Medical Device Regulatory Submissions from a document control standpoint • Responsible for Quality Records management per FDA requirements and according to company Control of Records SOP (document retention, storage, compliance, etc.) • Manage External Documents: Standards, maintenance of current revisions, etc. • Scan documents as needed and work involving conversion of paper-based to electronic Part 11 compliant electronic records system • Provide personnel training on Document Control processes and procedures as required