Beschreibung

In this role, you will be at the forefront of quality assurance, coordinating QA efforts throughout project phases and ensuring compliance with cGMP standards. Your day-to-day responsibilities will involve reviewing critical documentation and managing stakeholder relationships while supporting regulatory inspections.

Anforderungen

• •Academic degree in Biotechnology, Biochemistry, or related field
• •Significant experience in biopharmaceutical manufacturing, preferably in QA
• •Strong background in cGMP and biotechnological manufacturing processes
• •Sound experience in representing Quality and Compliance in projects
• •Good communication skills and experience in interaction with interfaces
• •Experience in TrackWise, LIMS, DMS, and SAP preferred
• •Excellent written and spoken English; knowledge of German advantageous

Aufgaben

• •Coordinate QA interests during project phases
• •Manage project-specific QA operations during commissioning and qualification
• •Review and release Standard Operating Procedures (SOPs)
• •Finalize Master Manufacturing Batch Records
• •Assess Material Specifications and Quality Risk Assessments
• •Handle deviations, CAPAs, and change requests
• •Conduct effectiveness checks and testing protocols
• •Independently manage stakeholder needs in a customer-focused environment
• •Participate in regulatory inspections and customer audits

Tools & Technologien

Benefits