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

CSL Behring; Göttingen; Hybrid; EUR 50.000 - 70.000; Vollzeit

Zusammenfassung

A global biotherapeutics company in Göttingen is seeking a GxP-Auditor to conduct qualification audits across EMEA. The ideal candidate will have fluency in English, Italian, and German, with 2-3 years of auditing experience. Responsibilities include risk analysis and compliance evaluations, all within a dynamic international team. Competitive salary and professional development opportunities are offered.

Leistungen

Personal and professional development opportunities

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.

Aufgaben

• Perform qualification audits in the EMEA region.
• Conduct risk analyses and evaluate qualification status.
• Assist in the development of audit systems and procedures.

Kenntnisse

Language skills in English, Italian and German

Analytical and solution-oriented thinking

Teamwork and interpersonal skills

Ausbildung

Vocational training or bachelor's degree in public health or natural sciences

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

Your 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 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 bachelors 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.

Our 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.

About CSL Plasma

CSL Plasma operates one of the world a 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

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. 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 Inclusion and Belonging | CSL.

Do work that matters at CSL Plasma!