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/IT/DE (full-time / permanent)
Your responsibilities:
1. Performance of qualification audits in the respective national language (EN/IT/DE) in the EMEA region at plasma suppliers / service providers according to GxP and DIN ISO and evaluating the audit results
2. Performance of risk analyses and evaluation of the impact on the qualification status of the plasma supplier / service provider; evaluation of corrective / preventive measures
3. Review implementation and compliance with regulations and CSL quality requirements for all facilities to be audited
4. Assist in further development of the established audit systems
5. Assist in the creation and editing of standard operating procedures
6. Update various work lists to provide metrics up-to-date provision of key performance indicators
7. Electronic acquisition and processing of non-conformance reports
8. Participate in the implementation of trainings and workshops
Your profile:
9. Successfully completed vocational training or completed bachelor's degree in public health, natural sciences or similar area
10. 2 - 3 years of professional experience as an auditor preferred but also career changers are welcome
11. Excellent language skills in Italian, English and German (business fluent), french language skills are a plus
12. Willingness to travel intensively with a high degree of flexibility
13. Sound knowledge of quality management and GxP/DIN ISO area as well as audit/inspection experience preferable
14. Analytical and solution-oriented thinking skills as well as structured and independent working style
15. Ability to assess and interpret complex regulations
16. Ability to work in a team and to handle disputes as well as strong personal and social skills
17. Confident handling of MS Office standard software
Your Benefits:
18. Opportunities for personal and professional development e. g. further training as GxP-Auditor
19. A highly varying as well as demanding and responsible area of work
20. Pleasant working atmosphere in an international, dynamic, and high-performance team
About CSL Plasma
operates one of the world’s largest and most sophisticated plasma donation networks, with nearly 330 donation centers in the U.S. and Europe. CSL Plasma is a subsidiary of CSL, a global biopharma company. Plasma collected at CSL Plasma facilities is used by CSL for the sole purpose of manufacturing lifesaving plasma-derived therapies for people in more than 100 countries. The parent company, (ASX:CSL; USOTC:CSLLY), headquartered in Melbourne, Australia, employs 29,000+ people.