Internal Quality & Compliance Auditor

Internal Quality & Compliance Auditor

Job Title: Internal Quality & Compliance Auditor
Contract Type: Permanent
Location: Dublin
Salary: Negotiable
Start Date: ASAP
Reference: HQ00055126_1491553532
Contact Name: Rachel Radford
Contact Email:
Job Published: April 07, 2017 09:25

Job Description

Reporting to the Quality Systems Manager the Internal Quality and Compliance Auditor is accountable for leading the following function: management and delivery of Internal and External Audit programmes.

Key responsibilities:

  • Conducts audits of data, information, procedures, equipment and systems, and/or facilities to ensure the compliance with SOP's and GMP's and worldwide regulations.
  • Develops maintains and re-evaluates the audit schedule.
  • Assists in the development of audit plans and schedules.
  • Assembles and coordinates the activities of the audit team.
  • Ensures audit team are adequately trained.
  • Conducts audits in accordance with standard operating procedures and quality policies.
  • Interprets policies, standards, and regulations, and then evaluates potentially critical problems not covered by the policies, standards, and regulations.
  • Ensures written procedures are followed, and exercises judgment in evaluating quality systems, processes, procedures, and protocols for compliance.
  • Escalates compliance issues.
  • Communicates audit results to management and auditees through written audit reports. May be required to present to Senior Management on audit reports.
  • Manages post-audit activities, and follows up on any necessary corrective and preventive actions by resolving any conflicts.
  • Assists with preparation, hosting and follow up of regulatory facility inspections
  • Drafts and issues periodic reports to individual site management as requested.
  • Assists with training/orientation for new Quality Auditing staff.
  • Monitoring and evaluating risk management, how the business is governed and internal processes are working.
  • Anticipating emerging issues through research and making recommendations on how best to deal with them.
  • Support product and facility inspections, preparation of procedures and instructions including certification assessment and surveillance audits, supplier audits
  • Identify processes, situations, etc., where organisation is meeting requirements, as well as identify opportunities for improvement
  • Assist audit team in developing audit reports.
  • Develop internal audit metrics /testing parameters

Key Requirements

  • Primary degree qualification in a science or engineering discipline
  • Minimum 8 year experience in in vitro diagnostics, Medical Device /Pharmaceutical or related industry
  • 3 years of audit experience in GMP environment preferred
  • Experience with Global regulatory audits / inspections (FDA, HPRA, WHO)
  • Development / Maintaining a Quality Management System; successful implementation of continuous improvements to QMS
  • Building and leading effective teams, and highly motivated individuals
  • Previous experience with government /regulatory agency with a working knowledge of cGMP regulations.
  • Experience in technical report writing.
  • Analytical Problem solving skills.
  • Continuous improvement skills.

If you are interested and you feel that your skill set is a good match for this role, don't hesitate to apply!

Get similar jobs like these by email

By submitting your details you agree to our T&C's