Process Quality Excellence Specialist

CK Group are recruiting for a Process Quality Excellence Specialist to join a biopharmaceutical company in a hybrid role, on an initial 12-month contract basis. Contract inside IR35
The Role:
The main purpose of the role will be to:

• Support the Head of Process Quality Excellence in developing and maintaining its clinical quality systems/procedures
• Ensure quality and compliance risks are appropriately identified and mitigated
• Actively include all aspects of clinical studies that are managed by Global Clinical Sciences and Operations with a focus on GCP
• Review regulations and changes, performing gap analysis, to update SOPs after identifying how new regulations might affect existing processes

Your Background:
To succeed in this role, you will come from a Life science background with experience from global Quality Assurance or a Clinical Development setting.

• In depth experience of GCP, including hands on experience in global GCP audits and/or inspections.
• Previous experience in SOP writing essential.

Apply:
It is essential that applicants hold entitlement to work in the UK. Please quote job reference 56517 in all correspondence.