Deputy Responsible Person Wholesale/QM Manager GDP

Deputy Responsible Person Wholesale/QM Manager GDP

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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 date for a

Deputy Responsible Person Wholesale/QM Manager GDP

to join our team

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

Seniority level

Seniority level
Mid-Senior level

Employment type

Employment type
Full-time

Job function

Job function
Quality Assurance
Industries
Pharmaceutical Manufacturing and Wholesale

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