Location: Field Based/Home Working/Flexible
Job type: Permanent / Full-time
Company: Acceler8 Clinical Research
An exciting opportunity has arisen for an experienced GCP Quality Assurance (QA) Auditor to join Acceler8 Clinical Research, a fast-growing global, full-service clinical research organisation (CRO).
The role offers the opportunity to work within a dynamic, international CRO. 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.
We are seeking an experienced GCP QA Auditor to join Acceler8 Clinical Research to plan, organise and report internal and external audits in support of Acceler8’s audit schedule and that of other client organisations. This position will report to the QA Manager.
- 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
- Conducting follow up activities where required
- Performing trend analyses on audits conducted
- Liaise with Acceler8’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
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 (minimum 4 years) 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. 50%).
Acceler8 Clinical Research has offices in the UK, Australia and Singapore. We operate throughout Europe, North America, South America, Asia, Africa and Australasia. Our expanding company provides clinical trial services and support to the pharmaceutical and medical device sector.
Acceler8 Clinical Research offers the opportunity to work on clinical trials of real scientific merit, genuinely working in partnership with our Clients to help deliver new treatments for unmet needs. Working within a highly motivated team, you can make an impact and see your talents rewarded.
This is an exceptional opportunity to join Acceler8 Clinical Research. Our employees are vital to our success and we are seeking candidates to join our company and grow with us.
As a progressive organisation embracing the work/life balance, we offer fantastic opportunities for personal development and advancement as well as competitive salaries, company pension scheme, private healthcare, share options, and life insurance.
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: 4 years (Required)
- planning, performing and reporting an audit: 4 years (Required)
- quality assurance auditing: 4 years (Required)
- prior vendor qualification auditing experience (preferred)
- CSV auditing experience (Preferred)
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Reference ID: GCP QA Auditor – UK