Sr Quality Specialist

vor 1 Monat


Marburg, Deutschland IQVIA Vollzeit

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.



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