Dana Graupner
CTA
Experience
CTA
- 4 years of experience in quality control at a pharmaceutical manufacturer
Quality Analyst
- 14 years of experience in quality assurance of biotechnological aseptic API manufacturing
- conducting quality improvement projects in the area of quality (operational excellence)
Managing Director & Consultant
Qualitätswandel Prozessoptimierung GmbH
- project management and interim management including team leadership in quality assurance
- consulting and supporting stakeholders
- building and maintaining a quality management system
- deviation and change management
- preparing ISO- and GMP-compliant documents
- planning, qualification and maintenance of clean rooms, including routine monitoring through microbiological and particle monitoring
- risk assessment according to ISO 14971 and ICH Q9
- validation of computer-based systems
- planning and conducting supplier audits as lead auditor, including contract manufacturing management
- support during inspections by authorities and notified bodies
- training and coaching
- batch release and BRR
- development and implementation of quality metrics
- project leadership
- team leadership
Summary
Results-driven consultant with solid, long-term experience in quality management & operational excellence in pharmacies, medical device manufacturing and the pharmaceutical industry
Skills
Communicative
Leadership Skills
Responsible
Quick Comprehension & Problem-solving Skills
Result-oriented
Resilient
Flexible
Strong Communicator With The Drive To Implement Positive Changes
Project Management And Interim Management Including Team Leadership In Quality Assurance
Consulting And Supporting Stakeholders
Building And Maintaining A Quality Management System
Deviation And Change Management
Preparation Of Iso- And Gmp-compliant Documents
Planning, Qualification And Maintenance Of Clean Rooms, Including Routine Monitoring Through Microbiological And Particle Monitoring
Risk Assessment According To Iso 14971 And Ich Q9
Validation Of Computer-based Systems
Planning And Conducting Supplier Audits As Lead Auditor, Including Contract Manufacturing Management
Support During Inspections By Authorities And Notified Bodies
Training And Coaching
Batch Release And Brr
Development And Implementation Of Quality Metrics
Project Leadership
Team Leadership
Consulting
Process Optimization
Lean Management
Clean Room Planning And Qualification
Mindset And Behavior Coach
Iso 9001 Certification
Ms Office
Mac Os
Adobe Sign
Sharepoint
Trackwise
Sap/pls/mes
Languages
Education
Certified Industrial Master, Pharmacy specialization · Pharmacy
Chemical Lab Technician · Chemistry
Certifications & licenses
Certified Industrial Master, Pharmacy specialization
ISO Lead Auditor Training IRCA ISO 9001
Qualified instructor with AdA certificate
ISO 9001 certification
Profile
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