Qualified Person (m/f/x) | Frankfurt | Pharma
As team member of the Quality Operations department at this pharmaceutical production site, you will be responsible for the market release of medicinal products in accordance with § 15 Abs. 1 AMG. As a Qualified Person you will ensure the dossier compliant production of all medicinal products. You will be significantly involved in deviation management and change control as well as in customer complaints with regards to compliance with dossier conformity and GMP principles. You will work closely with the supplier qualification team in the qualification of new raw materials. You are also the central contact person for quality-related questions.
Your tasks as "Qualified Person (m/f/x)"?
- Implementation and maintenance of Quality Assurance procedures for our commercial and developmental products, performing QA reviews and representation in audits and authority inspections
- Ensuring compliance of operations with current GMP and expectations, enhancing quality policies, systems and procedures as appropriate
- Carrying out legal duties of a QP as specified under EU legislation
- Liaising with company divisions and external suppliers
Your requirements as "Qualified Person (m/f/x)"?
- University degree in pharmacy
- Qualification as a Qualified Person and assumption of the function according to §15 AMG
- Experience working as a qualified person in the pharmaceutical industry
- Good knowledge of national, European and international regulations for medicinal products
- Very good IT skills (MS Office, etc.)
- Knowledge of Biological Medicinal Product and Investigational Medicinal Product desired.
- Very good knowledge of German and English
- Team and communication skills, flexibility
Information about our client:
Our client is a research-based human health care company that discovers, develops and markets pharmaceutical products throughout the world. They are employing over 10.000 people across R&D, manufacturing sites and marketing subsidiaries. They are delivering innovative products in various therapeutic areas with high medical needs in oncology and neurology.
I look forward to your application!