- Reference: AJ45547
- Job Type: Permanent
- Location: Dublin West, International, Leinster
- Category: Science, Pharmaceutical & Food
The QA Compliance Auditor will perform evaluations for compliance with US and foreign regulation requirements and provide evaluation of quality related systems for suppliers that provide materials, services and products to The Client. Suppliers can include API suppliers, contract labs, excipient suppliers, commodity suppliers, devices, specialty pharmacies, logistic providers and third party manufacturers.
QA Compliance Auditor responsibilities:
- Assess compliance of systems, facilities, and procedures through audits and assessments of suppliers.
- 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 at the supplier.
- The position serves a tactical purpose for the client and must achieve a difficult balance of involvement and objectivity.
- Participate in strategic initiatives to improve compliance to regulatory requirements and standards.
Education & Experience:
- Bachelor’s Degree preferably in technical or scientific area (Chemistry, Pharmacy, Biology, Microbiology, or Engineering) or equivalent industry experience (at least 4 years) 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.
- 2+ years in Quality Assurance with some project management experience in the pharmaceutical, medical device/nutritional or related industry.
- One year in compliance/auditing is required. Total combined experience expected to be at least 6 years.
- ASQ certification desired, not required.
- Fluent in English.
For more information or to apply please contact Tina Egan on email@example.com 09064 78104.
Please Note: Collins McNicholas will not forward your details to any company without your prior approval.
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