GxP Auditor (m / f / d) with italian or french language skills + fluent D / EN

CSL Plasma GmbH; Göttingen; Vor Ort; EUR 50.000 - 70.000; Vollzeit

Zusammenfassung

CSL Plasma GmbH is seeking a GxP-Auditor for its Quality Assurance Department in Göttingen. The role includes performing qualification audits at plasma suppliers, evaluating compliance with regulations, and enhancing audit systems. Ideal candidates will possess a bachelor's degree in public health or a related field, excellent language skills, and experience in quality management.

Leistungen

Attractive remuneration with additional pension benefits

Opportunities for personal and professional development

Mobile working possible

Pleasant working atmosphere in an international team

Qualifikationen

• 2-3 years of professional experience as an auditor preferred.
• Fluent in English and German, additional Italian or French is a plus.
• Willingness to travel intensively with flexibility.

Aufgaben

• Perform qualification audits in the EMEA region at plasma suppliers.
• Evaluate audit results and implement corrective measures.
• Assist in the development of audit systems and standard procedures.

Kenntnisse

Analytical thinking

Solution-oriented thinking

Teamwork

Social skills

Ausbildung

Bachelor's degree in public health or natural sciences

Vocational training as interpreter or foreign language correspondent

Tools

MS Office

Jobbeschreibung

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 foreign language skills in IT or FR + fluent in DE / EN

• 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 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.
• Excellent language skills in English and German plus Italian or French
• 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.
• 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.
• Mobile working possible.
• Attractive remuneration with additional pension benefits.