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IQVIA Sr Quality Specialist in Marburg, Germany

  • Duties and Responsibilities:

  • Provide coordination and oversight and ensure GCLP compliance regarding equipment qualification, calibration and maintenance, Change management as well as Deviation & CAPA management

  • Validation Owner for computerized systems and IT-applications

  • Ensure timely completion of processes and workflows

  • Manage equipment SOPs lifecycle as well as qualification and validation documents

  • Supports the implementation of new quality requirements

  • Drive spot checks, audit/inspection preparation and audit/inspection follow up

  • Manage spot checks for the lab areas in coordination with QA

  • Support preparation of audits / inspections (documentation and logistics)

  • Support CAPA plan development and ensure timely follow up in response to audit & inspection observations

  • Participation in regular meetings locally and globally in order to ensure harmonization of procedures and processes

  • Requirements :

  • Bachelor's degree in biology, biochemistry, life science or a similar degree program.

  • At least three years of professional experience in the relevant field, ideally in the qualification, calibration and maintenance of GCLP compliance equipment

  • Experience of working in a GxP environment

  • Very good written and spoken German and English language skills

  • Good computer skills (especially MS-Office package).

Q² Solutions, IQVIA’s laboratory business, creates connected intelligence by combining our expertise, technology and analytics - this fuels unparalleled research & development solutions. We uphold a deep commitment to patients, sites, customers, and each other. https://www.q2labsolutions.com/careers

IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.

To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.

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