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CSL Plasma is one of the world's largest human plasma production companies for the manufacture of highly effective coagulation and immunoglobulin products.

For our Quality Assurance Department in Göttingen we are looking for a

GxP-Auditor (m/f/d) with excellent language skills in EN/DE PLUS Italian OR French

(full-time / permanent)


Aufgaben

  • Performance of qualification audits in the respective national language (EN/IT/FR/DE) in the EMEA region at plasma suppliers / service providers according to GxP and DIN ISO and evaluating the audit results

  • Performance of risk analyses and evaluation of the impact on the qualification status of the plasma supplier / service provider; evaluation of corrective / preventive measures

  • Review implementation and compliance with regulations and CSL quality requirements for all facilities to be audited

  • Assist in further development of the established audit systems

  • Assist in the creation and editing of standard operating procedures

  • Update various work lists to provide metrics up-to-date provision of key performance indicators

  • Electronic acquisition and processing of non-conformance reports

  • Participate in the implementation of trainings and workshops


Profil

  • Successfully completed vocational training or completed bachelor's degree in public health, natural sciences or similar area

  • 2 - 3 years of professional experience as an auditor preferred but also career changers are welcome

  • Excellent language skills in Italian or French plus English and German (business fluent)

  • Willingness to travel intensively with a high degree of flexibility

  • Sound knowledge of quality management and GxP/DIN ISO area as well as audit/inspection experience preferable

  • Analytical and solution-oriented thinking skills as well as structured and independent working style

  • Ability to assess and interpret complex regulations

  • Ability to work in a team and to handle disputes as well as strong personal and social skills

  • Confident handling of MS Office standard software


Wir bieten

  • Opportunities for personal and professional development e. g. further training as GxP-Auditor

  • A highly varying as well as demanding and responsible area of work

  • Pleasant working atmosphere in an international, dynamic, and high-performance team

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