QA GCP Auditor

Proclinical is seeking a QA GCP Auditor to based in Camberley on a permanent basis. This Conduct internal and external GCP audits. Facilitate closure of audit findings, assist with root cause analysis (RCA) and action plan development and drive corrective actions to completion. . Advise Clinical Development on the implementation of effective, compliant, standardized 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. Assist in developing and conducting GCP training for in-house and clinical investigational staff

Job Responsibilities:

• Conduct internal GCP audits of Clinical Development systems and processes including Biometrics.
• Conduct external GCP audits of vendors, investigational sites and CRO to ensure that company
• studies are being performed and documented in accordance with the principles of GCP. Coordinate and analyse audits conducted by third parties.
• Facilitate closure of audit findings, assist with root cause analysis (RCA) and action plan development, drive corrective actions to completion and conduct effectiveness checks. Maintain tracker, implement and present metrics.
• Maintain the Global Clinical Quality Assurance (CQA) Audit Schedule, track progress, implement and present metrics.
• Provide guidance and direction to company 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.
• Assist with the development and conduct of GCP training for in-house and clinical investigational staff.
• Assist with the coordination and implementation of inspection readiness activities.
• Assist with hosting Regulatory Authority inspections
• Advise Clinical Development on the implementation of effective, compliant, standardized 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
• Draft inspection readiness plan and coordinate implementation of inspection readiness activities.
• Ensure 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).
• Excellent written and verbal communication skills. Ability to communicate assertively with tact and diplomacy.
• Strong leadership, project management and organisational skills.
• A team player who can work well with peers and senior medical personnel and deliver pragmatic but sound quality solutions to identified issues.
• Willing and able to travel to conduct global audits and meetings (up to 40 % travel).

To Apply:

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 call Owen Bach on +44 203 8261 330 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.