Personal Information
Organization / Workplace
Frankfurt Am Main Area, Germany Germany
Occupation
Director Quality Auditor & Consultant
Industry
Medical / Health Care / Pharmaceuticals
About
Creative and results-oriented professional with almost 20 years of experience managing operations, production, compliance, regulatory affairs and development at corporate and department levels in pharmaceutical industry. Unique combination of experience in the SME sector and multinational groups. Excellent knowledge of the drug development process – from idea to launch. Successful in establishing QA systems. Initiated GMP Lead Auditor certification procedure by IRCA.
Specialties: - GMP compliance and audits (incl. Quality Assurance systems building and compliance maintenance)
- EudraLex vol. 4 / cGMP / ICH Q7/Q8/Q9/Q10
- CAPA / remediation plans management
- Pharmaceutical regulatory af...
Contact Details
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