Olaf Kasemann

- Validation & Qualification Services - GXP-Compliance - Project Management - Interim Management MFG & QA & Eng

- Process Validation, Cleaning Validation, Method Validation, Validation of Aseptic Filling Processes, Down-Scale Validation Definition of Requirements for Validation Documentation, Development of Validation Master Plans, Risk Assessments and corresponding further documentation - Qualification of Production Equipment, Utilities, Critical Systems (HVAC, WFI, PW, CS, CA), Computer Systems, Analytical Equipment - Project Management / Manager of Validation and Qualification Tasks, Technology Transfers

- Development of Process Validation Concept for Vienna Facility, Establishment of Statistical Process Control (SPC) - Management of Cleaning Validation - Establishment of harmonized production processes at the Vienna facility and major production facilities - Management of Technology Transfer und Registration Projects, Development of corresponding documentation - Interface Function to Departments of the Major Facilities (Regulatory Affaires, Process Evaluation and Validation, Manufacturing, Virus Validation

- Production Manager, Production and final packaging of granulates, tablets and coated tablets, sterile und non sterile ointments, sterile und non sterile solutions und suspensions - Main Responsibility for sterile Products (Liquida & Ointments) - Management of Technology Transfer Projects - Responsible for Contract Manufacturing and Auditing, Production - Auditing of Production by Authorities und Contractors