Siglinde Dürr

Quality Management

• Provide QA Services to pharma/biotech companies:
• Implement Quality Systems for pharmaceutical products (GMP/GCP), medical devices (ISO 13485) or clinical laboratories (ISO 17025, 15189)
• Develop and establish Standard Operating Procedures
• Support in streamlining processes
• Conduct GCP/GMP trainings

Auditing

• Perform GMP compliance audits, Mock-GMP Inspections of biotechnology, pharmaceutical and API manufacturers
• Perform vendor/supplier audits
• Perform GCP audits at investigational sites, CROs, clinical laboratories
• Document (study protocol/study reports) and TMF Audits

More than 20years’ experience in implementation and maintenance of quality systems according to EU and US requirements; special expertise in biotech products and medical devices, auditor for GMP and GCP ystems

Education:

Biologist (Diploma)
Certified Auditor

Experience:

Vice President Quality Management Fresenius Biotech GmbH
Director Quality Assurance and Quality Control, Medigene AG

Areas of Expertise:

Quality