Clinical QA Auditor
A global healthcare company that focuses on Interventional Medicine is currently recruiting a Clinical QA Auditor, joining their team in Surrey, UK. This company bring markets medical products that meet the needs of specialist healthcare physicians and their patients. This vacancy is an exciting opportunity to work with a dynamic company that prides itself on its growing portfolio of products that advance the treatment of cancer, vascular conditions, and severe emphysema.
The QA Auditor will conduct internal and external GCP audits whilst facilitating the closure of audit findings, assisting with root cause analysis (RCA) and action plan development, and driving corrective actions to completion. They will also advise Clinical Development on the implementation of effective, compliant, and standardised processes and systems (QMS) that enable the company's clinical investigation-studies to be performed in compliance with relevant country Good Clinical Practice (GCP) Regulations. Finally, they will assist in developing and conducting GCP training for in-house and clinical investigational staff
- Conducting internal GCP audits of Clinical Development systems and processes, including Biometrics.
- Conducting external GCP audits of vendors, investigational sites, and CROs to ensure that studies are being performed and documented in accordance with the principles of GCP.
- Coordinate and analyse audits conducted by third parties.
- Facilitating the closure of audit findings, assisting with root cause analysis (RCA) and action plan development, driving corrective actions to completion, and conducting effectiveness checks. Maintain tracker, implement and present metrics.
- Maintaining the Global Clinical Quality Assurance (CQA) Audit Schedule, tracking progress, and implementing and presenting metrics.
- Providing guidance and direction to Development and Clinical staff on pertinent GCP standards to enable development of SOPs and compliant systems that fulfil GCP requirements for International and local Regulatory Agencies as well as ethics committees.
- Assisting with the development and conduct of GCP training for in-house and clinical investigational staff.
- Assisting with the coordination and implementation of inspection readiness activities.
- Assisting with hosting Regulatory Authority inspections
- Advising Clinical Development on the implementation of effective, compliant, and standardized processes and systems (QMS) that enable clinical investigation-studies to be performed in compliance with relevant country Good Clinical Practice (GCP) Regulations.
- Drafting inspection readiness plan and coordinate implementation of inspection readiness activities.
- Ensuring that all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished with quality and in accordance with company values.
Skills and Requirements:
- BS or equivalent in Pharmacy, Nursing, Biology, Pharmacology, or allied health science subject. Higher level degree is preferred.
- Experience in clinical quality assurance or equivalent. Experience in a CRO or a research-based healthcare company.
- Experience in a leadership or training role would be an advantage.
- A sound understanding of Good Clinical Practices as interpreted by the global regulatory authorities.
- At least two years of GCP auditing experience both internal and external (vendors and investigational sites).
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Steven Fuller at +44 203 854 2630 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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