We are currently sourcing a QA Compliance Auditor to join a global QA Audit & Compliance team. In this role, you will perform evaluations for compliance with US and foreign regulation requirements and 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.
- Assess compliance of systems, facilities, and procedures per applicable regulations through audits and assessments of our suppliers, assuring compliance to regulatory requirements and 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 at the supplier.
- The position serves a tactical purpose for the client company and must achieve a difficult balance of involvement and objectivity.
- Participate in strategic initiatives to improve compliance to regulatory requirements and standards
- Bachelor's Degree preferably in technical or scientific area and 4+ years experience in 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.
- Effective communication skills are essential with an ability to work effectively outside of the company and across functional and technical areas.
- This role involve 50% travel internationally.
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
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