Beschreibung

In this role, you will oversee the quality and GMP compliance of IT/OT systems, ensuring that projects meet regulatory standards. Your daily responsibilities will include reviewing records, coordinating investigations, and mentoring team members to ensure successful audits.

Anforderungen

• •University degree in life science or engineering
• •Minimum of 5 years of experience in Quality Assurance at a biologics manufacturing site
• •Practical experience in Quality Oversight for major IT/OT systems
• •Practical experience in Technical Change Control, Deviation Management, and CAPAs
• •Outstanding communication skills
• •Mastery of teamwork in a diverse environment
• •Strong acumen across relevant GMP regulations
• •Ability to drive quality awareness by integrating regulatory requirements
• •Excellent German and English language skills, both written and spoken
• •Highly desirable special experience in green field / brown field CAPEX projects
• •Implementation of new production or automation technologies

Aufgaben

• •Provide end-to-end quality oversight on GMP-compliance for IT/OT systems
• •Ensure GMP-compliance in projects and system lifecycle activities
• •Serve as the QA partner for key systems like MES and SAP S/4HANA
• •Review and approve GMP records for Technical Change Control and CAPAs
• •Coordinate complex deviation investigations and root cause analyses
• •Present topics during health authority inspections and internal audits
• •Mentor technical experts in inspection preparation and presentation