Job Description
Job Purpose
The Senior Specialist Drug Product and Device (GxP) provides comprehensive support to Technical Operations and perform essential oversight of Good Manufacturing Pratice (GMP) compliance for Drug Product (DP) and Device vendors. They will manage all Quality-related issues, oversee CAPAs, Change Controls, and handle GMP-related Temperature Excursions and Technical Complaints, collaborating effectively with the rest of the MoonLake Quality team, the Technical Operations team and consultants (where necessary).
This role is responsible for the receipt, assessment, investigation, documentation, and closure of technical complaints in accordance with GxP regulations (including GMP, GCP, and GDP, as applicable). The role ensures that all technical complaints, such as device issues, temperature excursions, packaging defects, or product quality concerns, are managed in compliance with internal procedures and regulatory expectations and are appropriately recorded, investi...