MAH QA Compliance Specialist | PTA (m/w/d)

Job Summary

This specialist role supports the Quality Assurance team, focusing on compliance activities related to Marketing Authorization Holder (MAH) responsibilities within a major international pharmaceutical company. The core daily tasks involve the complete lifecycle management of Pharmaceutical-Technical Complaints (PTCs), including their intake, processing within the electronic Quality Management System (eQMS), and managing incoming complaint samples according to established guidelines. The specialist is responsible for forwarding PTCs for investigation, diligently tracking resulting investigations, and monitoring the implementation of Corrective and Preventive Actions (CAPAs). Furthermore, the role involves supporting the creation of response letters to complainants, conducting data evaluations on PTC processing, and assisting with critical document management tasks (e.g., MIA, PQRs). This position requires a scientific educational background, significant GxP experience, and strong communication skills to thrive in a highly regulated, multinational, and multicultural environment.