Berlin Metropolitan Area
• Management and review of validation and qualification activities • Development and implementation of validation concepts according to current regulations and guidelines • Technical Change Control • Deviation and CAPA Management (equipment calibration) • Preparation and support for audits and inspections • Training employees
• Deviation and CAPA Management • Investigations on OOE and OOS results • Ensuring manufacturing according to GMP regulations and Manufacturing Descriptions • Signing of Batch Records according to §13 (8) AMWHV • Process Optimization, Troubleshooting • Support for Change Control procedures • Support for Equipment Acquisition, Qualification Projects, Product Acquisition, Due Diligence Studies • Training employees on GMP and other pharmaceutical topics
• Optimization of Manufacturing Processes for Solid Dosage Forms • Troubleshooting • Transfer and Reformulation Projects, Feasibility Studies • Process Validation • Assurance of Data Integrity • Support for Change Control procedures • Support for Equipment Acquisition, Qualification Projects, Product Acquisition, Due Diligence Studies • Training employees on GMP and other pharmaceutical topics