Sr Quality Specialist

• 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