About the Role The Quality Management System is a crucial component of our organization, ensuring compliance with regulatory standards and global quality guidelines. As a key member of our team, you will support the QA Manager in executing and improving the system, aligned with GMP, GDP, and local regulations. Responsibilities: - Manage complaints, deviations, and change controls to maintain regulatory compliance. - Spearhead medical device inspections to ensure adherence to industry standards. - Collaborate with the QA Manager to implement and refine quality management processes. Requirements: - Demonstrate intermediate-high English proficiency for effective global communication. - Possess a degree in Pharmaceutical Chemistry or a related field. - Hold current registration and professional license with INVIMA. - Showcase experience in the pharmaceutical industry, specifically in quality, product release, pharmacovigilance, and GMP/GDP compliance. - Familiarize yourself with relevant regulations, such as Resolution 4816 of 2008 (Pharmacovigilance). Desirable Skills: - Pursue training as an internal auditor to enhance your skillset. - Demonstrate expertise with systems like TrackWise, SAP (LE/WM), Mango, Excel, and SharePoint. - Cultivate knowledge of validation processes, document management, and activities related to product release and transportation.