Quality Management Representative (m/f/x)

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Date: 09-Nov-2018

Location: Pfaffenhofen an der Ilm, Germany, 85276

Company: Daiichi Sankyo Europe

Legal Entity: Daiichi Sankyo Europe GmbH

 

 

Passion for Innovation. Compassion for Patients.™

Daiichi Sankyo and its 15.000 employees in more than 20 countries are dedicated to the creation and supply of innovative pharmaceutical products. The group’s 2025 vision is to become a “Global Pharma Innovator with Competitive Advantage in Oncology”. Our research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology. Our European headquarters are in Munich, Germany and we have affiliates in 12 European countries. For more information please visit: www.daiichi-sankyo.eu.

 

For our location in Pfaffenhofen we are seeking highly qualified candidates to fill the position:

 

Quality Management Representative (m/f/x)

 

 

Key responsibilities:

  • Participation in conception and local implementation of company-wide quality standards
  • Collaboration in globally active QM working groups
  • Representation of company QM systems to third parties
  • Participation in defining basic quality assurance principles for DSE
  • Verbal and written consultation and information of company management and individual departments in all areas on QM-related matters
  • Verbal and written consultation and information of company affiliates in QM relevant matters
  • Involvement in self-inspections and audits at the company, company affiliates or third parties on request
  • Quality Management of Contract Manufacturing Organizations (CMOs)
  • GMP/GDP Support of Company Affiliates
  • Preparation and participation in customer audits and regulatory inspections
  • Execution of and participation in GxP-related trainings
  • Contribution in preparation of QM documentation at individual areas of the company and the company at all (“SOPs”)

 

Professional experience and personal skills:

  • Completed scientific or technical university education, Ph.D. favorable
  • Practical experience in the field of quality assurance for several years, preferred in pharmaceutical industry
  • Excellent GMP and GDP knowledge
  • Experiences in participating in GMP/GDP inspections by international authorities
  • Professional skills in English language
  • Intercultural Communicative Competence
  • Ability to work in an international matrix Quality Organization
  • General skills in Information Technology

 

What we offer:

 

We offer an interesting, diversified and challenging position, good contractual conditions, flexible working models, all the social benefits of a modern company and a professional environment where you will have the opportunity for personal growth.

 

Please apply online at our Career Portal. We are looking foward to hearing from you.