Manager Manufacturing

Management of manufacturing in accordance with § 12 AMWHV with a focus on the import of medicinal products and investigational medicinal products, ensuring the timely import and testing of batch records for products that comply with specifications. Active participation in the quality system, including the creation and revision of procedural instructions, forms, and lists. Tasks include confirming the review of batch records, ensuring products are manufactured, imported, tested, and stored in accordance with regulations, and ensuring manufacturing records are checked for accuracy. Ensuring GMP-compliant maintenance, qualification, and re-qualification of all rooms, facilities, devices, and equipment. Assisting in the selection, qualification, and monitoring of external manufacturers and import service providers.