Senior Scientist, Compliance and Maintenance Support Quality Control(m/w/x)

Beschreibung

You will ensure laboratory excellence by managing QC equipment lifecycles and compliance. Your day-to-day involves troubleshooting technical issues and leading investigations to maintain audit readiness.

Anforderungen

• •Degree in Molecular Biology, Chemistry, Biochemistry, Chemical Engineering, or related discipline
• •Equivalent professional experience in lieu of formal education
• •Experience in GMP-regulated laboratory environment
• •Experience with analytical laboratory equipment and maintenance
• •Proficiency in technical English, German is advantageous
• •Commitment to quality, compliance, and data integrity
• •Detail-oriented with risk-based problem solving approach
• •Independent work and cross-functional team collaboration
• •Excellent communication, organizational, and prioritization skills
• •Interest in digitalization and analytical system modernization
• •Motivation to develop technical and regulatory expertise

Aufgaben

• •Investigate deviations and manage assigned change controls
• •Author, review, and update GMP documentation
• •Perform gap assessments and execute remediation actions
• •Support inspection and audit readiness for health authorities
• •Participate in health authority and customer audits
• •Serve as subject matter expert for QC equipment maintenance
• •Coordinate maintenance activities for laboratory equipment
• •Qualify and re-qualify new and existing QC equipment
• •Manage the lifecycle of QC equipment and applications
• •Provide technical troubleshooting for QC laboratories
• •Support OOX and OOS investigations
• •Collaborate with engineering, IT, and quality functions

Tools & Technologien