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.
EEO Minorities/Females/Protected Veterans/Disabled