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Employer Fastnet The Talent Group
Job Title Site Audit Lead
Description


Responsibilities:

  • Actively manage, mentor, and support site auditors to ensure performance of auditors contributes to the effectiveness of the site audit program
  • Function as a change agent related to culture and audit program performance
  • 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.
  • Ensure timelines and quality of content for audit execution (audit pre-work, conducting audit, issuance of audit report, CAPA review and verification) meet established expectations.
  • Perform, lead, and mentor other auditors during site audits; participate in opportunities to audit at regional sites.
  • Review, and approve Audit Reports
  • Actively monitor, report and trend observations/CAPAs, along with standard site audit metrics to Quality Council and Management
  • 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
  • Recommend and lead implementation of improvements to the Audit and Inspection Management programs based on new regulations, guidance documents, and industry standards
  • Lead company and site preparation activities for support of regulatory and customer inspections
  • Provide compliance advice to site, development and commercial product teams
  • Supports and continually enhance the ongoing site Permanent Inspection Readiness status
  • Obtain and maintain cutting-edge knowledge and auditing techniques across applicable technical/Quality topics
Requirements

  • 5-10 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/or Drug Product
  • Experience in GMP auditing of Computerised System, Supplier Management and Logistics/Warehousing
  • Experience working directly with regulators in audit situations
  • Ability to build relationships and influence across disciplines and all levels
  • Should be highly motivated, flexible, and have excellent organisational and communication skills
  • Excellent verbal and written communication skills
  • Ability to prioritise and balance work from multiple projects in parallel
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.

Fastnet - The Talent Group
'Not Just Placers.........Partners'

The Life Science Specialists

This job originally appeared on RecruitIreland.com
Location Carlow
Date Added 13 days ago
Apply Link
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