Freelance Pharma Consultant

10/2022 – 5/2023

Implementation of a Data Integrity Program
• Create process flows, data flow diagrams and respective risk assessments
• Execute (IT) system assessments and respective risk assessments
• Document all activities and results according to Good Documentation Practices and guidelines
• Tracking and implementing remediation activities according to the remediation plans

Quality Assurance Engineer

5/2022 – 7/2025

Implementation of a global Enterprise Recipe Management (ERM) and Process Knowledge Management (PKM) System.
• Identify customer needs and direct these to the ERM organization
• Support internal business process alignment, standardizations and ensuring compliant operation procedures
• Act as a local ERM subject matter expert for the site/ organization
• Train new staff including performing on the job training
• Conduct peer review of recipes to ensure alignment with guidelines

Knowledge Management

1/2019 – 12/2022

• Project Manager for the implementation and validation of two computerized systems (CSV)
• Responsible person and subject matter expert for the training system and document management
• Creation and processing of SOPs, deviations, CAPAs, change requests, risk assessments and PQRs
• Evaluation and site-specific implementation of global quality guidelines
• Subject matter expert for microbiological monitoring
• Planning, execution and follow-up of GMP self-inspections

Dokumentenmanagement, Good Manufacturing Practices