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| Phaidon International | ||
US-NV, Freelance Quality Assurance Manager 452431244356-MZ | ||
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| Quality Assurance Manager – Netherlands My client, a global pharmaceutical company, is looking for a freelance Quality Assurance Manager for a 6 month contract, 0.6 FTE, starting in July 2015. This will be located in the National Capital Region of The Netherlands. Main Responsibilities - Ensure design control compliance - dentify applicable quality and regulatory requirements - Review and approve all project deliverables (internal and from suppliers) - Participate to risk management and usability engineering processes in accordance with ISO 14971 and IEC 62366 - Participate to design reviews, approves/disapproves move to next phase - Compile the Technical File, ensure CE mark approval - Support regulatory submissions worldwide - Ensure alignment with drug development and regulatory teams - Participate to supplier qualification and audits - Review and approve change control, deviations and CAPAs - Assess new or revised regulations and standards Desired Skills and Experience - 5+ years in Quality Operational or Systems Management position - Strong understanding of EU GMP & CFR regulatory requirements, Quality Systems, Auditing, - Batch Release & Deviation / CAPA Management / Specific knowledge of manufacturing pharma and / or biological products - Medical device and drug-device combination regulations for the EU and US | ||
Please visit our website at www.phaidoninternational.com | ||
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