The QA Manager Audits & Inspections GCP GLP will lead and participate in various types of GCP/GLP compliance audits development programs including but not limited to, clinical investigator sites, service providers, and internal systems and processes globally. In addition, this position is responsible for supporting regulatory agency inspections.
• 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)
• Participate in strategic planning of organizational activities, as required.
• Support inspection management lead to maintain R&D inspection readiness at times
• Participate in regulatory agency inspection activities pertinent to R&D
• Domestic and international travel is required
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
Knowledge/understanding of the perspectives of regulatory agencies
4-year degree OR 10+ years’ industry experience plus applicable industry certifications Industry certification in Regulatory Affairs and/or Quality Assurance is preferred but not required.
For further information on this QA Manager, Audits & Inspections GCP / GLP position please contact Laurentina Kennedy at The RFT Group on 01 2302400 / firstname.lastname@example.org. Check out all our open jobs on our Recruitment website: www.rftgroup.ie Follow us on Linked-in,