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

CSL Plasma is one of the world's largest human plasma production companies, specializing in the manufacture of highly effective coagulation and immunoglobulin products.

GxP-Auditor (m/f/d) with foreign language skills in IT or FR + fluent in DE / EN

Your responsibilities:

1. Perform qualification audits in the respective national language (EN / IT / FR / DE) within the EMEA region at plasma suppliers and service providers, ensuring compliance with GxP and DIN ISO standards, and evaluate audit results.
2. Conduct risk analyses and assess their impact on the qualification status of plasma suppliers and service providers; evaluate corrective and preventive measures.
3. Review the implementation and adherence to regulations and CSL quality requirements across all audited facilities.
4. Assist in the development of established audit systems.
5. Contribute to the creation and revision of standard operating procedures.
6. Update work lists to ensure metrics and key performance indicators are current.
7. Manage the electronic collection and processing of non-conformance reports.
8. Participate in training sessions and workshops.

Your profile:

1. Completed vocational training or a bachelor's degree in public health, natural sciences, or equivalent; or vocational training as an interpreter or foreign language correspondent.
2. 2-3 years of professional experience as an auditor is preferred; career changers are also welcome.
3. Excellent language skills in English and German, plus Italian or French.
4. Willingness to travel extensively with a high degree of flexibility.
5. Solid knowledge of quality management, GxP / DIN ISO standards, with audit/inspection experience preferred.
6. Analytical, solution-oriented thinking skills, with a structured and independent work style.
7. Ability to interpret and assess complex regulations.
8. Strong team player with good dispute resolution skills and excellent personal and social skills.
9. Proficient in MS Office applications.
10. Additional foreign language skills are highly advantageous.

Your benefits:

1. Opportunities for personal and professional development, including further training as a GxP-Auditor.
2. A dynamic, demanding, and responsible work environment.
3. A friendly and international team fostering a high-performance culture.
4. Competitive salary with additional pension benefits.

We prioritize your well-being because it matters. Learn more about how we care at CSL.

About CSL Plasma

CSL Plasma is among the world's largest collectors of human plasma, dedicated to helping individuals with rare and serious diseases lead healthier lives. We are committed because lives depend on us. Discover more about CSL Plasma.

Our commitment to diversity

As a global organization with employees in over 35 countries, CSL values inclusion and belonging. Learn more about our Inclusion & Belonging initiatives.