Lead Investigator

Description

The Lead Investigator leads the complaint investigations and trending process for Roche products, including Devices, Combination Products, and Drug Delivery Systems, with a focus on the Port Delivery System (PDS). The scope of accountability includes complaint investigations where material was used in clinical trials or supplied to the commercial market. The overall aim of this work is to respond to issues in the market (or clinic) and to identify trends and issues that affect the overall state of control of products and their manufacturing process, and, if necessary, identify appropriate actions for product quality issues.
Additionally, the Lead Investigator:
• Responsible for executing, reviewing and approving records in the Quality Management System (including Complaints, Deviations, CAPA, .
• Identifies, analyzes, and drives the resolution of complex issues related to or identified with complaints processes.
• Provides training and guidance ...