Job Description
My client a leading Pharmaceutical company now require a Lead Internal Auditor to join their expanding team.
The Lead Internal Auditor is responsible for leading the internal audit program on site, including supporting regulatory and customer inspections. The Quality Compliance Specialist will have specific and varying duties as assigned by the Quality Systems & Compliance Manager.
This is a permanent role based in Dublin and it comes with a good salary with good benefits.
Lead Quality Compliance Specialist
- Manage the internal audit programme including preparation of annual schedule
- Execution of internal audits as per schedule
- Oversight of GMP Inspections and Quality on the Shop Floor program
- Prepare all associated documentation including audit plans and audit reports
- Reporting on metrics and KPIs to senior leadership team
- Communication of audit findings to individual departments and senior leadership team
- Follow-up on CAPA actions identified ensuring closure in timely manner
- Establishment of site internal audit team
- Training of internal audit team as required
- Lead regulatory Health Authority and Customer Inspections as required, including acting as SME for specific topics as necessary
- Act as compliance subject matter expert regarding GxP Interpretations for all levels of Management
- Perform external audits of suppliers as necessary
- Participate in cross-functional project teams as the quality compliance representative
- Participate in Continuous Improvement programmes
- Participate in other projects as directed by the Quality Systems & Compliance Manager.
- Flexibility is important and responsibilities may change, or other duties may arise for this position
Requirements of Lead Quality Compliance Specialist
- Primary Degree in a scientific discipline
- 7+ years’ experience in a GMP setting
- Qualified Internal Auditor preferred
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The RFT Group, BioPharmaceutical Division specialize exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors.
For more information please contact John at The RFT Group / www.rftgroup.ie / 01 2302400 or click apply below