QA Compliance Auditor
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| Job Type | Permanent |
| Area | Mayo, IrelandSligo, IrelandDublin, IrelandCork, Ireland |
| Sector | Quality |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | 3084 |
| Job Views | 1268 |
- Description
- Team Horizon is seeking a QA Compliance Auditor for a Multi-National Pharmaceutical company in Ireland. This is an exciting opportunity to join a Global team and assist and support the Internal Audit and Compliance Team in performing evaluations for compliance with US and foreign regulation requirements.
Why you should apply:
This is an excellent opportunity to join a diverse and talented team whose focus is to help patient live healthier lives.
There is opportunity for career progression, along a generous benefits package and the chance to travel globally.
What you will be doing:
You will work with the Internal audit team to provide constructive evaluation of quality related systems for suppliers that provide materials, services and products. (Suppliers can include API suppliers, contract labs, excipient suppliers, commodity suppliers, devices, specialty pharmacies, logistic providers and third party manufacturers. )
Assure that activities are performed and documented in accordance with company policies/procedures and applicable quality and regulatory requirements intended to assure the quality, effectiveness and safety of our products
With guidance from other members of the Internal Audit team; assess compliance of systems, facilities, and procedures per applicable regulations through audits and assessments of our suppliers, assuring compliance to regulatory requirements and company specifications.
Provide feedback in the form of audit observations, and review corrective actions to determine if corrective actions and commitments have been properly implemented, proven to be effective and are being maintained by the supplier.
Support strategic initiatives to improve compliance to regulatory requirements and standards.
75% Travel is required for this role
Any other duties as assigned
What you need to apply:
Bachelor’s Degree preferably in technical or scientific area (Chemistry, Pharmacy, Biology, Microbiology, or Engineering) or equivalent industry experience with sufficient exposure to pharmaceutical, medical device, or combination product related industries.
Must have a technical background and requires understanding of the audit process and knowledge of worldwide requirements related to GMP regulations for quality systems and compliance.
Must understand a variety of quality/operational systems that support facility, product design, development, production, distribution, installation, support, and service and understand the principles of quality management.
The individual must have excellent oral/written communications skills. ·
Personal skills needed include interpersonal skills, tact, open mindedness, maturity, tenacity, self-reliance, organizational/administrative skills, and sound judgment.
One year in Quality Assurance with some project management experience in the pharmaceutical, medical device or related industry.
One year in compliance auditing is required. Total combined experience expected to be at least two years.
Fluent in English. Including reading, writing and verbal communication.
