Description
A multinational medical device company is looking for multiple complaints management specialists to support the Complaint Management team in a Quality Improvement program with multiple projects.The scope of the projects will be to drive compliance with FDA/GMP requirements and to improve internal communication.
Start: July 2014
Duration: 12-18 months
Location: Canton Zurich, Switzerland
Responsibilities
• Support projects within the complaints team including:
Post market surveillance
Field action procedures
Vigilance reporting
Market withdrawal including lot tracking and lot blocking
• Review related documentation to improve adherence to regulatory requirements
• Review complaint SOPs and align to best practice and regulatory requirements
• Provide input relating to strategy and ideas for improvement and advise the department within scope and ensure implementation of quality related knowledge, procedures and guidelines
• Support the drive to improve the feedback loop from post market surveillance into the design control process
• Help to determine ongoing processes for quality and regulatory requirements for new products
Job requirements
• Extensive experience in a GMP/Quality related role within medical device or pharmaceutical industry
• Experience in complaint management
• Experience with continuous improvement and lean thinking, is an asset
• Quality and compliance driven
• Good interpersonal skills
• Ongoing focus on identification and realisation of improvement potential
• Good written and oral communication skills in English essential