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)
Your responsibilities
- 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
Your profile
Successfully completed vocational training or completed b