Korschenbroich, North Rhine-Westphalia, Germany
- Project management in pain medication (tablets, solution, patches) and management of analytical product transfers with different sites world wide - Testing and release of final medicinal products, semi finished goods and raw materials in compliance with cGMP, AMWHV and Pharm. Eur. - Organization of an analytical QC lab with supervision of direct reports (technicians) incl. budget planning - Handling and processing of OOS/OOE, deviations, changes and CAPAs - Method validations - Writing of GMP documents (testing monographs, transfer documents, validation and qualification documents, SOPs)
- Project management (diagnostics) and product transfers from different development sites across Europe with focus on qPCR - Testing and release of finished products (diagnostic kits) and stability studies in compliance with cGMP, MPG and ISO13485 - Organization of an analytical QC lab with supervision of direct reports (technicians) incl. budget planning - Handling and processing of OOS/OOE, deviations, changes and CAPAs - Writing of GMP documents (SOPs, stability protocols and reports) - Responsibility for documentation, staff-and equipment qualification
- Head of laboratory and "Leiter der Qualitätskontrolle - Lead of Quality Control" for inhalation products. QC Testing and release of final products, stability studies and IPCs in xompliance with cGMP guidelines and AMWHV/USP/Pharm.Eur.. - Management and supervision of lab staff. - Responsibility for testing equipment and QC documentation incl. testing monographs and instructions as well as SOPs. - Management of CAPAs, deviations, OOS/OOE investigations and quality events. - Collaboration with international drug product development teams.