Quality Specialist, Audit and Inspection Findings and CAPA

The Quality Specialist, Audit and Inspection Findings and CAPA ensures Ergomed groups Audit and Inspection Findings and CAPAs are managed in compliance with global regulations, legislation and internal requirements. 

Leadership and Compliance: 

• Provide support and guidance to Ergomed colleagues and functional teams in developing, managing, and implementing Audit and Inspection Findings and CAPAs. 
• Ensure GxP activities are conducted in compliance with applicable legislation, guidelines, and standards, including ICH, CIOMS, and ISO. 
• May act as the Subject Matter Expert to Ergomed group staff over Audit and Inspection Findings and CAPAs and requirements related to GxP Quality Operations as required. 

Training and Development: 

• Guide Audit and Inspection Findings and CAPA training activities across the Ergomed group, ensuring employees are adequately trained to meet global GxP requirements and client expectations, with support from the Learning and Development team. 

Quality Management System Oversight: 

• Participate in efficiency projects to enhance the use and management of the Ergomed Group Quality Management System. 

Audit and inspection Support: 

• Provide support to functional and Quality teams for audits and inspections by supplying reports or procedures from the Ergomed Group Quality Management System. 

Metrics and Reporting: 

• Assist in the preparation and analysis of team related metrics, providing periodic reports to management. 
• Take a role in preparing any required CAPA or Deviation records resulting from issues in the Audit and Inspection Findings and CAPAs. 

Team Leadership and Development 

• Assist in mentoring and leading the Audit and Inspection Findings and CAPA team helping to develop team members and to build competence, confidence, and subject matter expertise. 
• Foster a collaborative, high‑performing quality culture across global teams and regions. 
• Provide coaching and professional development opportunities to enhance team capability and succession planning.