Posted to MedZilla on 2/16/2020

EPM Scientific

US-NV, Freelance Quality Assurance Manager 452431244356-MZ


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

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