Engineer, Quality Assurance CAPA III

PURPOSE STATEMENT

Manage the resolution of exception reports linked to the Quality System (NCRs, PRAs) and audits, providing support in the review and approval of the relevant documentation for the processes mentioned, including problem definitions, investigations, audit responses, action implementation, and others. Ensure compliance with standards (GMPs) and the safety, quality, and finance regulations defined by the company.

MAJOR RESPONSIBILITIES

1. Review and approve documents derived from exception reports related to the Quality System in order to document the outcome of the investigation process, including containment, correction, and prevention actions that address the root cause of the finding, as well as the mechanism to verify the effectiveness of the actions implemented.
2. Act as SME in working sessions for quality system events with experts from the areas involved in the finding, in order to develop the investigation an...