GXP Quality Consultant
Our client launched a First-in-Human (FIH) study last July that is going well. It is a small molecule Alzheimer’s program. In support of that they need to continue to build/update their Quality Management System (QMS) and stay on top of their audit plan.
SCOPE & RESPONSIBILITIES:
- Maintenance of Quality Management System documents including policies, standard operating procedures and the Quality Manual
- Creating and overseeing the execution of the audit plan across GLP, GMP and GCP functions
- Review of CDMO/CRO documents where Quality oversight is required (but not necessarily be the signatory approver)
- Leadership of the Quality Committee including leading the investigation of any significant quality events and the execution of appropriate corrective and preventive actions (CAPA) as required.
- Needs a true GxP person. (They are an N of one)
- 9 months+ contract
- ~20 hours/week
- ASAP Start
Interested parties please send your CV and cover letter, or summary of your experience by clicking the link below.Send Us An Email