GxP-Auditor (m/f/x)
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/x) with foreign language skills in EN/DE
(full-time)
Your responsibilities:
Performance of qualification audits in the respective national language (EN/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.
Your profile:
Successfully completed vocational training or completed bachelor's degree in public health or natural sciences area or successfully completed vocational training as interpreter or foreign language correspondent.
2 - 3 years of professional experience as an auditor preferred but also career changers are welcome.
Language skills in 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.
Additional foreign language skills are very welcome.
Your Benefits:
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
Mobile working possible
Pleasant working atmosphere in an international, dynamic, and high-performance team.
Attractive remuneration with additional pension benefits.
Please send your detailed application to:
CSL Plasma GmbH, QA_SQ EMEA, Ute Cherfan, Weender Strasse 75 in 37073 Göttingen (Germany) or by email to ute.cherfan@cslplasma.com
Wir möchten, dass Sie sich bei CSL wohl fühlen. Das ist wichtig und Sie sind es auch. Erfahren Sie mehr darüber, was wir bei CSL bieten.
CSL Plasma betreibt eines der weltweit größten Netzwerke von Spendezentren für menschliches Blutplasma. Mit unserer Arbeit tragen wir dazu bei, dass Menschen mit seltenen und schweren Krankheiten ein normales, gesundes Leben führen können. Wir engagieren uns für unsere Arbeit, weil Menschenleben von uns abhängen. Erfahren Sie mehr über CSL Plasma.
Als globales Unternehmen mit Mitarbeitenden in über 35 Ländern steht CSL für Vielfalt, Fairness und Inklusion. Erfahren Sie mehr über Vielfalt, Fairness & Inklusion bei CSL.
