Beschreibung
I am currently seeking a CAPA Senior Consultant to provide site-specific implementation and monitoring of standardized procedures, processes and systems to deliver consistent CAPAs compliant with internal standards and Medical Device Regulations.Main Duties & Responsibilities
-Maintain overall management and effectiveness of the CAPA system.
-Roll-out and maintain site CAPA review Boards including scheduling, execution and minutes.
-Deliver education and interactive training for CAPA users in order to maintain compliance including Failure Investigation, CAPA Review Board and CAPA Content.
-Ensure processes are in place to alert management of product quality & compliance issues for proper and timely escalation to CAPA.
-Provide CAPA compliance metrics and weekly management tracking reports.
-Highlight quality risk and design/implement mitigation activities.
-Facilitate Change Management activities resulting from the standardisation of the CAPA process and associated systems.
-Liaise with EU CAPA Manager to establish and implement internal policies, procedures and quality objectives.
Key Competencies Required
-Mandatory Languages: English and German.
-System design and management skills (Organizational and Quality Systems).
-Expert knowledge of the US Quality System Regulations and ISO 13485.
-Demonstrated track record of delivering best in-class results in the Quality Systems area.
If you are interested in this project or need further information please send your CV directly to Beni Wehrle. You can call me on .
Keywords: CAPA consulting, quality assurance, CAPA review board, compliance metrics, Change management, SOP, FDA, ISO , Medical Devices, German and English, Switzerland, Freelance
Campaign Ref: CH
To find out more about Real please visit www.realstaffing.com