GxP-Auditor (m/f/d) with excellent Italian skills + fluent in DE/EN

CSL Plasma; Göttingen; Vor Ort; EUR 45.000 - 65.000; Vollzeit

Zusammenfassung

A leading plasma production company in Göttingen is seeking a GxP-Auditor to conduct audits across the EMEA region. The ideal candidate will have strong language skills in English, Italian, and German, along with experience in quality management. The role requires a team player with analytical skills, offering opportunities for personal and professional development. Competitive compensation and additional benefits are included.

Leistungen

Opportunities for personal and professional development

Attractive remuneration with additional pension benefits

Pleasant working atmosphere in a dynamic team

Qualifikationen

• 2 - 3 years of professional experience as an auditor preferred.
• Willingness to travel intensively with a high degree of flexibility.
• Sound knowledge of quality management and GxP/DIN ISO area.

Aufgaben

• Perform qualification audits in EMEA region at plasma suppliers.
• Conduct risk analyses and evaluate corrective measures.
• Review compliance with regulations and CSL quality requirements.

Kenntnisse

Language skills in English

Language skills in Italian

Language skills in German

Analytical thinking

Teamwork skills

Ausbildung

Vocational training in public health or natural sciences

Vocational training as interpreter or foreign language correspondent

Tools

MS Office standard software

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 EN/IT/DE (full-time / permanent)

Responsibilities

• 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.
• 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 and 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, Italian 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.
• Pleasant working atmosphere in an international, dynamic, and high-performance team.
• Attractive remuneration with additional pension benefits.

We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

CSL Plasma operates one of the world’s largest and most sophisticated plasma collection networks, with over 350 plasma collection centers in the U.S., Europe and China. Headquartered in Boca Raton, Florida, CSL Plasma is a subsidiary of CSL Behring, a global biotherapeutics business and a member of CSL. Plasma collected at CSL Plasma facilities is used by CSL Behring for the sole purpose of manufacturing lifesaving plasma-derived therapies for people in more than 100 countries. The parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people.

We want CSL to reflect the world around us. Inclusion and Belonging is at the core of our mission and who we are. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more about Inclusion and Belonging at CSL.

Do work that matters at CSL Plasma!