Quality Systems Specialist presso Insud Pharma

Support the development of Quality Systems in collaboration with Site and Global Quality teams.

Extract and analyze data from various internal and external compliance platforms and propose improvement actions for the organization.

• Data Analytics: Extract and analyze data from the Global TrackWise Digital system, along with various internal and external compliance platforms. Communicate quality or compliance concerns with urgency.

• Documentation and Compliance: Write and revise Perform Investigations and Root Cause Analysis in Global Trackwise Digital system utilizing quality assurance skills. Ensure compliance with regulatory requirements, such as Good Practices (GxP) and other relevant guidelines.

• Risk Assessment and Mitigation: Conduct risk assessments, implement risk controls, and monitor ongoing compliance to minimize the impact of risks on global quality operations.

• Continuous Improvement: Prepare and monitor quality system records using the TrackWise Digital system. Contribute to defining and ensuring the timely completion of quality system actions. Provide supporting information for quality records, including reasons and justifications.

A bachelor's or master's degree in medical technology such as Computer Science, Chemistry or Engineering is required. Professional certifications in quality system management can be advantageous.