Job Description

The successful Compliance Specialist will work with an Engineering team and support their work in managing compliance on services of a GMP and Non-GMP basis that may have an impact on production.

This role would be the point of contact liaising with Quality and managing the appropriate engineering and facilities response to compliance matters. You will be the Inspection Readiness Point of Contact.

The role would require someone skilled in the following:

• COMET / or Equivalent (Trackwise)
• Change Control
• Non-conformance management
• RCPS and Investigations lead 
• CAPA / Corrections Developer
• Truvault 
• SOP Development 
• Form Development 
• Periodic Review
• Engineering Compliance Meetings
• Meeting lead and support of same
• Story board development
• Oversight on Training timeliness.