Internal Quality & Compliance Auditor
|Job Title:||Internal Quality & Compliance Auditor|
|Contact Name:||Rachel Radford|
|Job Published:||April 07, 2017 09:25|
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.
- 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
- 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!
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