Frankfurt Rhine-Main Metropolitan Area
- Planning of investigational medicinal product supply - Discussion of the study design with involved parties - Cooperation with medical and clinical affairs departments, manufacturing plants (production and quality units), contract manufacturers and authorities - Preparation of the clinical labeling information - Ordering of the IMP Supplies - Organization of IMP distribution and single shipments - GMP relevant tasks - GMP-GCP interface tasks - Second step release of the IMP - Compilation of the required IMP documentation - Quality Assurance tasks - GDP audits - Assisting by GCP audits - SOP development
- Monitoring and compliance of requirements for the manufacture of drugs according to GMP-quidelines (solid dosage forms for the pharmaceutical and healthcare industries) - Manufacturing process monitoring, corrective and preventive actions (granulation, tabletting, coating, sugar-coating departments) - Manufacturing process optimization - Manufacturing process validation - Pharmaceutical formulation and product development (solid dosage forms) - Intermediate and final product quality control and release - Writing and approval of validation plans and reports (manufacturing process) - Checking and adaptation of manufacturing instructions to the state of science and technology as well as to the state of authorization documents, approval of the BMI - Documentation of deviations and evaluation of the deviation cause
- Drugs QC analytical laboratory trainee - Manufacturing process monitoring (granulation, tableting, coating, sugar-coating and packaging departments) - Intermediate and final product quality control (solid dosage forms for the pharmaceutical and healthcare industries) - In Process Control (solid dosage forms) - Dissolution testing of retard drug products (Sotax equipment)