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.
- 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
- 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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