DirecciónQMS Specialist (Trackwise)Location: Madrid (Onsite)Reports to: Quality Systems Manager The role: Assist in the enhancement of Quality Systems through cooperation with Site and Global Quality teams. Extract and assess data from diverse internal and external compliance platforms, suggesting organizational improvement actions. The responsibilities:Data Analytics:Extract and analyze data from the Global TrackWise Digital system and various internal/external compliance platforms. Promptly communicate concerns related to quality or compliance. Documentation and Compliance:Draft and update procedures. Conduct Investigations and Root Cause Analysis in the Global Trackwise Digital system, leveraging quality assurance expertise. Ensure adherence to regulatory requirements, including Good Practices (GxP) and other pertinent guidelines. Risk Assessment and Mitigation:Perform risk assessments. Implement and oversee risk controls to uphold ongoing compliance and minimize the impact of risks on global quality operations. Continuous Improvement:Create and monitor records within the TrackWise Digital system for quality system purposes. Contribute to the definition and timely completion of quality system actions. Provide comprehensive supporting information for quality records, including justifications and reasons. Your background: Expertise in the Pharma Industry and Quality Assurance. Excellent knowledge of international GMP requirements, Quality systems, and relevant guidelines. Experienced in pharmaceutical industry deviations, investigations, CAPA, and TrackWise Digital System processes. Proficient in documenting quality activities, creating procedures, and preparing compliance reports. Bachelor's or master's degree in medical technology (Computer Science, Chemistry, or Engineering). Professional certifications in quality system management are advantageous. Fluency in Spanish and English; knowledge of other languages is an asset. Over 3 years of experience working within QA/Pharma industry. Email Applicants please forward to; jake.
