Inka Petzelt
graduate engineer (chemical technology, specialising in biotechnology)
Ms Inka Petzelt has many years of experience in global projects and international approval procedures. She combines in-depth technical know-how with comprehensive expertise in regulatory affairs, quality management and corporate coaching. Her focus is on providing companies with reliable and efficient support in national and international approvals, compliance processes and quality management systems. She also holds an MBA (Switzerland).
Core competencies
- Regulatory affairs & approval: medical devices, in vitro diagnostics, medicinal products, food supplements, cosmetics, veterinary medicinal products
- Quality management: development, optimisation and implementation of QM systems (ISO 9001, ISO 13485, ISO 14001, KTQ, EFQM)
- Business coaching: Process optimisation, product development, efficiency improvement at management level
- Project management: research and development projects, international approval projects, quality assurance projects
Professional background
- Since 2005 – Managing Director, pci petzelt-consulting-international GmbH
Management of consulting projects on QM, regulatory affairs and process optimisation; supervision of international approvals and research projects - 2000 – 2005 – Technical Customer Service Manager Europe, US company for primary packaging for liquid medicines
Management of approvals and market launches, including for the Chinese market; project management of European quality assurance studies - 1996 – 2000 – Assistant to the QM Manager, biotechnology company
Development of QM systems (ISO 9001, ISO 13485), project management for microbiological detection systems at European level, training as an internal auditor