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Consulting for Quality Management & Computer System Validation
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Life Sciences
Profile
With more than 20 years of experience in quality assurance and computer system validation in an international environment, I have acquired a broad knowledge in the pharmaceutical and biotechnological sector as well as in the field of medical devices.
I advise, support and accompany you in general quality management topics as well as in GxP compliance requirements or computer system validation projects. Short-term or long-term, as long as you need my support.
I help small or medium-sized companies, teams or business units that are confronted with tasks that need to be successfully implemented or provide support in the operational implementation of projects at short notice.
With my independent solution- and service-oriented approach in this fast-paced, rapidly changing environment, I can help you to strengthen your company if you lack the internal human resources, specific know-how and consistent principles.
Strong organisational skills, a conscientious and structured way of working, the ability to successfully manage tasks and timelines, and to communicate complex regulatory requirements and processes in understandable language are what set me apart.
In-depth knowledge and understanding of regulatory requirements (GxP, FDA, MDR) as well as ISO 13485 and other relevant ISO standards, GAMP5, EU GMP Annex 11, 21 CFR Part 11 and many years of experience in the GxP regulated environment complete my profile.
Skills
Quality management & GxP
- Compliance and Governance
- Regulatory requirements
- GAP analysis and assessment
- Required procedures, processes and documents
- Process identification and definition
- Process and system optimization (management of changes, audits, complaints, CAPA, incidents, deviations, suppliers, documents, risks, training, etc.)
- QMS implementation
- Audit and certification (preparation, planning, conducting)
- Employee qualification
- Supplier qualification
- Quality technical agreements, Quality assurance agreements (QAA, QTA)
- Device and room qualification
- IT Infrastructure qualification
- GxP knowledge and experience (GCP, GCLP, GDP, GLP, GMP, GVP)
- Data protection (GDPR)
Computer System Validation (CSV/CSA)
- Process digitalization
- Computerized Systems (access systems, laboratory systems, production systems, storage systems, monitoring systems, labeling systems, analysis systems, archiving systems etc.)
- Software in regulated environments (electronic signature, document management, online training, QMS software, ERP systems, software for recording, evaluation and documentation of clinical trials, vigilance systems, regulatory submission software, CAQs, business process management software, etc.)
- Document framework
- Assessment, Strategy and concept
- Risk management
- Risk management
- Data integrity and compliance
- Data protection
- Data migration
- Test procedures
- Cyber security
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