Quality Assurance Consultant

Job Summary: The Quality Assurance Consultant is responsible for the implementation, maintenance, and oversight of the Quality Management System (QMS) in local affiliates. This role ensures compliance with regulatory requirements, quality standards, and company policies. The Quality Assurance Consultant will manage quality risk, complaints, change controls, deviations, CAPA, authority inspections, self-inspections, GxP surveillance, product quality reviews, training, local product release, and oversight of GDP requirements for local warehousing and distribution.

Key Responsibilities:

• QMS implementation, maintenance, and oversight in local affiliates.
• Maintenance of the local Quality Manual and Site Master File.
• Quality risk management in local affiliate, including risk identification, analysis, communication, control, and escalation as required.
• Complaint management, acting as the Local Complaint Coordinator for reporting, local asse...