An exciting opportunity has arisen for an experienced Senior GCP Quality Assurance (QA) Auditor to join our client, who are a specialised QA CRO. 

The role offers the opportunity to work within a dynamic, international company. This varied and exciting role allows the successful candidate the opportunity to develop and grow within our expanding company, supported by an enthusiastic and knowledgeable team. This is a remote position with travel to investigator sites for audits. 

We are seeking an experienced Senior GCP QA Auditor to plan, organise and report internal and external audits in support of the audit schedule and that of other client organisations. This position will report to the QA Manager.

• Planning and scheduling of GCP 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
• Conducting follow up activities where required
• Performing trend analyses on audits conducted
• Liaise with The Company's departmental heads to support implementation of business improvement initiatives
• Conduct internal audits/vendor audits
• Participate/lead internal/external projects such as gap analysis, QMS developments, training, QA support
• Maintain internal quality systems
• Assist in hosting client audits

PROFESSIONAL BACKGROUND & EXPERIENCE

The successful candidate will be educated to degree level or equivalent in a science subject with prior GCP auditing experience preferably in a pharmaceutical/clinical trial environment  of planning, performing and reporting an audit. Excellent knowledge of the requirements for compliance in clinical trials is required along with a very strong understanding of the clinical process, a full driving licence and a willingness to travel (approx. 40%).

Any offer of employment will be subject to the successful candidate holding the right to work in the UK.

• Prior GCP auditing including Investigator Site Audits in pharma/clinical trial (Required)
• Planning, performing and reporting an audit (Required)
• Quality assurance auditing (Required)
• Prior vendor qualification auditing experience (Required)
• CSV auditing experience (Preferred)

Please contact Gail Kniveton for more information. 

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