Qualified Person (m/f)

- Responsible for all the tasks foreseen by the Qualified Person according to what laid down in the relevant applicable Legislation
- Check that each batch manufactured in the plant or coming from a non-EEC Country has been manufactured and checked in compliance with the regulations in force and the conditions imposed during the medicinal product marketing authorization
- Prove with suitable documentation (compliance declaration) the compliance referred to above before placing the medicinal product on the market
- Ensure the correct storage of the said documentation and its total availability if requested by the regulatory authorities
- Promptly inform the Agencies, her/his corporate general manager and the holder of the authorization to place the medicinal product on the market, about any important irregularities found in the product already placed on the market
- Actively co-operate during health and regulatory audits and ensure the implementation of the operations requested by the auditors
- Monitor hygiene conditions and the efficiency of the manufacturing plant areas
- License as pharmacist and qualification as qualified person according § 14 AMG
- Experiences in GMP- guidelines and actually law and regulations
- Independence, reliability, communication skills and responsibility

Weitere Qualifikationen: Qualified person