Manager Manufacturing

The position involves managing manufacturing in accordance with § 12 AMWHV, focusing 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 is crucial, as is active participation in the quality system, including the creation and revision of procedural instructions, forms, and lists. Key responsibilities include confirming the review of batch records to ensure batches are manufactured in accordance with approved instructions, ensuring medicinal products are manufactured, imported, tested, and stored in compliance with regulations, and verifying the accuracy and completeness of manufacturing records before submission to the qualified person. Additionally, the role involves ensuring GMP-compliant maintenance, qualification, and re-qualification of facilities and equipment, proper validation of manufacturing and packaging procedures, and monitoring environmental conditions. Assisting in the selection, qualification, and monitoring of external manufacturers and import service providers is also required. The role also includes assisting in testing, release, and documentation of imported products, supporting compliance with GMP and GDP requirements, and participating in audits and inspections.