Manager, Audits & Inspections job in Oxford, England

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Last Name*

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Phone Number*

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Job type: Permanent

Discipline: Auditing

Location: United Kingdom

This vacancy has now expired. Please see similar roles below...

An exciting vacancy has arisen for a Manager in Audits & Inspections who will lead and participate in various types of GCP/GLP compliance for the development programs.

Job Responsibilities

Conduct/support GCP/GLP compliance audits of clinical investigator sites, service providers and internal system/process audits in accordance with the annual audit plan to determine compliance status and identify compliance risks
Prepare audit reports and communicate audit findings to audit stakeholders as well as R&D Quality Management ensuring understanding of observations
Collaborate with clinical compliance leads to identify audit needs and follow up post-audit activities to ensure appropriate implementation of CAPA, and monitoring successful completion of action items
Assist in managing and training external auditors ensuring compliance with auditing standards and procedures
Provide pertinent data to support quality and compliance metrics and trending
Assist in the planning of clinical quality audit programs
Develop and maintain study specific audit plans (SSAPs) and audit certificates
Participate in strategic planning of organizational activities, as required.
Participate in regulatory agency inspection activities pertinent to R&D

Skills and Requirements

Minimum 5 years pharmaceutical or biotechnology industry experience in performing audits and participating in regulatory inspections
GCP audit experience is required, GVP and GLP experience is valuable but not required
Knowledge/understanding of the perspectives of regulatory agencies
Bachelor's Degree in Business or Life sciences is required, advance degree is preferred
Ability to manage multiple priorities simultaneously and work efficiently in a fast-paced culture
Strong and clear understanding of Good Clinical Practices (GCP)
Must be disciplined, detail orientated and excel in personal time management
Collaborate and ability to interact all levels of the organization
Excellent written and verbal communications skills

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 contact Josh Godden on +44 203 854 0101 or upload your CV on our website - www.proclinical.com/send-cv

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