GxP-Auditor (m/f/d) with excellent Italian or French skills + fluent in GER/EN
Indexed description
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
- 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
- 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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