Head of Production (m/f)
According to law, the head of production is responsible for the production, storage, identification and addition of required package inserts according to the regulations on the market placement of drugs. This position includes a multitude of interesting tasks, for instance, personnel and production management, the qualification of machines and equipment and process validation. The head of production must also work with corporate quality assurance systems, since they are used to control and approve specific quality-relevant documents (GMP), manufacturing and testing regulations and standard operation procedures (SOP).
The position of the "head of production" does not only comprise demanding tasks, but also bears specific legal relevance. According to the German Drug Law (AMG), the person that holds the position of the head of production is one of the persons that must be named by a drug-producing company to receive a manufacturing authorization. The EC Directive 2001/83/EG on the "community code relating to medicinal products for human use" only speaks of a"Qualified Person".
The head of production must have a certain expertise which can be gained in the course of pharmaceutical studies. Also, he/she must prove two years of practical experience in a company that has been granted manufacturing authorization. According to the current AMG amendment no. 12, such practical activities must be performed in the field of drug manufacturing. Other academics such as chemists, biologists or doctors can qualify for manufacturing positions by respective complementary studies to gain the required pharamaceutical knowledge.