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Senior Gcp Auditor

3 months ago

Knutsford, United Kingdom CK GROUP Full time

CK Clinical are recruiting for a GCP Quality Assurance Auditor to join a fast-growing global clinical research organisation.
This will be a remote role but will require you to travel up to 50% of the time primarily in the UK.

**Responsibilities**:
As GCP Quality Assurance Auditor you will plan and conduct assigned internal and external audits to ensure that all activities are performed in compliance with relevant SOPs and ICH-GCP guidelines.
**Key duties will include**:

- Planning and scheduling of GxP audits requested by a client organization.
- Completion of audits by visiting the relevant site(s), interviewing staff and reviewing documentation according to the applicable regulations.
- Categorizing and classifying the audit observations, formally reporting these and proposing effective and efficient corrective/preventative actions where applicable.
- Reviewing corrective actions/action plans suggested by auditees.
- Leading internal/external projects such as gap analysis, QMS developments, training and QA support.

**Qualifications**:
As GCP Quality Assurance Auditor you will require:

- A life science degree.
- 5 years GCP auditing experience preferably in a clinical trial/pharmaceutical environment.
- Full driving license and a willingness to travel.

**Apply**:
It is essential that applicants hold entitlement to work in the UK. Please quote job reference 55230 in all correspondence.