The professions within the quality department converge around the drug manufacturing process, whether upstream, during or downstream of production. The quality department needs to combine technical, theoretical and scientific knowledges. A wide of positions are available to you. Here are a few examples.
The Quality Director, who is often also the Qualified Person for his site and therefore takes on this responsibility, draws up, implements and enforces the quality policy of the production site. He also organises and manages all the pharmaceutical operations of the plant. As one of his many missions, he will be required to review the quality of medicines, certification and batch release, to draw up declarations with his team to the ANSM (French Agency for the Safety of Health Production) or to manage non-conformities or complaints. Moreover, as a manager, leading and managing the staff of the quality department are major elements of his job.
The analytical technician has advanced technical skills to achieve complex analyses and interpret the results in order to assess the quality of health products in compliance with regulations and health and safety rules. During his analyses, he is responsible for pointing out non-conformities or deviations, evaluating them and making proposals to find solutions to the investigations. Moreover, other missions are offered to him such as participation in the transfer and validation of analytical methods or the drafting of documents related to his activity.
The Operational Quality Assurance manager defines and coordinates the implementation of the quality assurance policy by including control indicators. He is the responsible of the general Quality Assurance process which is set up and applied in the operational departments in accordance with the Good Practices and the site’s quality system guidelines. He also guarantees the availability of products on the market in compliance with the Public Health Code and GMP (Good Manufacturing Practices). Moreover, he also ensures compliance with safety standards and rules. Among his many missions, he will be required to conduct accreditation projects, supervises plants audits and optimises the quality management system.
The Compliance Manager is the responsible of the compliance of the site’s pharmaceutical activities and of the regulations for activities related to the introduction of new products. He also ensures the control for customers and suppliers activities and that the general quality assurance process is implemented and maintained in accordance with the public health code, GMP. At the same time, he manages risk analyses, works on continuous improvement projects, specifications and participates in customer audits.