Michael Kraft

- Managing of globally located contract manufacturer. - QA-Support to technical changes, e.g. new API supplier in alignment with affiliates and HQ-functions, e.g. procurement, product supply and regulatory affairs. - GMP survaillance and assessment audits - Supplier evaluation - Set up and maintenance of Quality Agreements - PQR/APR`s - QA-Support to launches and development projects - Operational Excellence Projects

Short Term Assignment - Quality Assurance

-Project manager for manufacturing site transfers of single and multi registered OTC products as well as nutritional and cosmetic formulations to internal sites & contract manufacturers. - Leading cross functional project teams for technical changes on OTC products, e.g. API supplier change, change of excepients, process changes & reformulations - Evaluation of new sourcing opportunities - Contribution in regulatory compliance initiatives - GMP Audits

Support of 12 sites world wide -Manage the implementation of Laboratory Infomation Management Systems (LIMS) incl Training, Installation, Validation and go live. -Laboratory Planning and Design -Instrument selection -IT-infrastructure -Robotic Systems -Know-how-Transfer and synergies between laboratories of regional sites -QA-expertise in due diligence projects -Lead and provide best practice guidance for QA/QC projects, e.g. transfers