Compliance Specialist
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 will serve as the point of contact, liaising with Quality and managing the appropriate engineering and facilities responses to compliance matters. Additionally, you will be the Inspection Readiness Point of Contact.
The role requires proficiency in the following areas:
1. COMET / or Equivalent (Trackwise)
2. Change Control
3. Non-conformance Management
4. RCPS and Investigations Lead
5. CAPA / Corrections Development
6. Truvault
7. SOP Development
8. Form Development
9. Periodic Review
10. Engineering Compliance Meetings
11. Meeting Leadership and Support
12. Storyboard Development
13. Oversight of Training Timeliness
#J-18808-Ljbffr