Kedrion Biopharma GmbH, a subsidiary of Kedrion S.p.A., is a pharmaceutical wholesaler that distributes finished medicinal products derived from human plasma for the treatment of numerous, sometimes rare and serious diseases such as coagulation and neurological disorders as well as immunodeficiencies in Germany, Austria, Poland and Portugal. The medicines are stored and distributed by a contracted logistics service provider.
Kedrion S.p.A., headquartered in Italy, is a steadily growing company that has expanded its global influence in the plasma processing industry. Kedrion S.p.A. is now one of the five most important suppliers of plasma products worldwide.
For our location in Gräfelfing, we are looking for the next possible candidate for a
Deputy Responsible Person / Quality Manager (m/f/x) GDP & Transport
Purpose of the function
In your role as Deputy Responsible Person / Quality Manager GDP you are the primary quality contact for logistics/distribution department. You will support the Responsible Person Wholesale according to §52a AMG in the management of quality-relevant activities in the area of storage, transport and distribution of medicinal products (pharmaceutical wholesale) and contribute to the implementation of and compliance with GDP and internal quality standards.
Roles and reposibilities
- Support of the Responsible Person in maintaining the quality system for wholesale and distribution activities
- Ensuring the implementation of and compliance with the requirements of the AM-HandelsV and the EU GDP guidelines in the distribution area and at our 3 PL service providers
- Authorisation and control of all outsourced activities that have an impact on good distribution practice
- Customer and supplier qualification
- Carrying out QA assessments in the context of logistics and quality deviations
- Deciding on the marketability of newly delivered, returned, rejected and recalled medicinal products or medicinal products suspected of being falsified
- Processing customer complaints and complaints about medicinal products
- Coordination and implementation of drug recalls
- Training, change control, risk, deviation and CAPA management
- Document management
- Carrying out internal and external audits
- Creation and management of quality-related documents and contracts
- Communicating internally with colleagues in the relevant Sales, Pharmacovigilance and Medical Affairs departments and externally with employees of contracted service providers regarding GMP/GDP-related issues and problems
Personal skills and professional experience
- University/FH/Master's degree in natural sciences or pharmacy or equivalent qualification
- Knowledge of the relevant laws, regulations and guidelines (AMG, AM-HandelsV)
- Experience and knowledge in the areas of GDP and GMP
- Experience and knowledge of quality assurance and management
- Experience with logistical processes desirable
- Strong communication skills, reliability, ability to work in a team
- Solution-orientated work and a structured way of working
- A high degree of flexibility and good self-motivation
- Hands-on mentality and strategic thinking
- Reliability and high quality awareness
- Fluent German and English (written and spoken)
- Experienced handling of modern IT infrastructure and common software