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Site Lead Auditor

Quality & Laboratory
Claire McGuckin
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Job Reference: JO-2010-65410_1602171913


An opportunity has arisen for a Site Lead Auditor. The Site Audit Lead will have leadership responsibility for the site internal audit program, encompassing the full scope of site operations. They are and SME & fully understand the Company's Audit Quality System. The position requires the ability to lead and perform the operational aspects of the audit program, apply risk-based principles, communicate results to stakeholders, and evaluate/verify CAPA closure.

Role Responsibilities

  • Effectively manage the site audit program
  • Actively manage, mentor, and support site auditors
  • Maintain a process on-site to ensure the site is Permanent Inspection Ready
  • Lead change and process improvement initiatives related to Auditing, Inspections, CAPA, and other compliance topics
  • Perform routine risk communication pertaining to audits/inspection to Site, Regional, and Divisional Management
  • Mentor new auditors to ensure comprehensive training and full understanding of auditor roles and responsibilities.
  • Achieve and maintain auditor qualification status through robust training and continuing education
  • Lead training/orientation for new Quality Auditing staff
  • Ensure preparation of annual audit schedule, using risk-based approaches.
  • Schedule and perform assigned audits for site program.
  • Perform, lead, and mentor other auditors during site audits; participate in opportunities to audit at regional sites.
  • Review, and approve Audit Reports
  • Actively participate and take a leadership role in the Auditor Community of Practice and Guest Auditor Program
  • Review and ensure CAPA responses to Audits and Inspections are robust
  • Perform a risk-based verification and effectiveness check on key CAPAs from audits and inspections
  • Lead company and site preparation activities for support of regulatory and customer inspections

Role Requirements

  • Minimum of 7 years Pharmaceutical industry experience within a GMP environment
  • Extensive knowledge of US and European cGMP guidelines, ICH and other international regulatory requirements
  • Extensive experience in GMP auditing across multiple Quality Management systems in API and Drug Product.
  • Experience in GMP auditing of Biologic, Vaccine and Sterile manufacturing facilities
  • Experience in GMP auditing of Computerised Systems including automation
  • Experience working directly with regulators in audit situations
  • Should have good project management skills
  • Qualification in lean methodology
  • Degree or 3rd level qualification (Science, Quality, Engineering).

Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.

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Claire McGuckin
Claire McGuckin
Business Unit Lead
Quality & Laboratory
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