Location: Field Based
Salary: £COMPETITIVE
Job type: Full time, Permanent
Company: Acceler8 Clinical Research
Location: Field based
An exciting opportunity has arisen for an experienced GMP Quality Assurance (QA) Auditor/GMP
Specialist 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.
ROLE OVERVIEW
We are seeking an experienced GMP QA Auditor/GMP Specialist 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. The role will also include providing GMP support to a wide variety of international clients. This position will report to the General 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 batch reviews
– Performing trend analyses on audits conducted
– Liaise with Acceler8 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
ROLE REQUIREMENTS
The successful candidate will be educated to degree level or equivalent in a science subject with prior GMP auditing/GMP support experience preferably in a pharmaceutical/clinical trial environment (minimum 3/4 years) of planning, performing and reporting an audit or providing support. 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. 25% – COVID restrictions depending).
Experience:
– planning, performing and reporting an audit: 3/4 years (Required)
– prior GMP auditing within pharma/clinical trial: 3/4 years (Required) AND/OR
– providing GMP support services to clients: 3/4 years
– quality assurance auditing: 3/4 years (Required)
Education:
– Bachelor’s (Required)
Licence:
– Driving (Required)
BENEFITS
This is an exceptional opportunity to join Acceler8. 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.
Acceler8 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.
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.
PRIVACY NOTICE
We want to reassure you that we take our data protection responsibilities very seriously. By applying for this role you are agreeing to our Job Applicant Privacy Policy and this can be viewed here: http://acceler8clinicalresearch.com/recruitment-privacy-notice
Any offer of employment will be subject to the successful candidate holding the right to work in the UK.
WE ARE SORRY BUT WE DO NOT ACCEPT APPLICATIONS FROM RECRUITMENT COMPANIES
Please email your CV, together with a covering letter, to admin@acceler8clinicalresearch.com
Reference ID: GMP QA Auditor – UK