QA Specialist CSV

At Elanco, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets.

We pride ourselves on fostering a diverse and inclusive work environment, where diversity is the driving force behind innovation, creativity, and overall business success.

As a global leader in animal health, we are committed to advancing the health of animals, people, the planet, and our enterprise.

Our team is passionate about making animals' lives better, and we're looking for talented individuals to join us in this mission.

Key Responsibilities:

• Implementation, assurance, and monitoring of GMP status and regulatory requirements for computerized systems throughout their lifecycle.
• Validation of computerized systems and verification of global CS applications at the site.
• Collaboration with the global CS validation team.
• Data analysis and management.
• Implementation of quality assurance-relevant activities.
• Self-inspection.
• Handling of deviations, changes, and cause analyses.
• Creation of quality-relevant documents (SOP, risk analysis, etc.).
• Verification and release of documents according to SOP specifications.
• Ensuring good documentation practice according to GMP.
• Implementation of Operational Excellence Management and a culture of continuous improvement, as well as establishing measures to prevent incidents.
• Participation in function- and department-crossing projects.

Requirements:

• Completed natural science or technical studies or equivalent qualification.
• Fundamental knowledge and experience in the field of validation of computerized systems, as well as experience in the pharmaceutical GMP environment, particularly in quality assurance, is advantageous.
• Excellent written and verbal communication skills (German and English).
• Ability to work independently, responsibly, and solution-oriented, flexibility, and analytical thinking.
• Self-initiative and willingness to take responsibility.
• High level of safety and quality awareness.
• Well-developed team spirit and high level of self-motivation.
• Good problem-solving skills.
• Experience in project management is desirable.

What we offer:

• Interesting and varied work environment in a modern and growing global company in the pharmaceutical industry.
• Freedom for self-initiative and flexibility.
• Exciting development opportunities.
• Company fitness.
• Meal allowance.
• Corporation benefits.
• Team events.
• 30 vacation days.
• Attractive remuneration including performance-based bonus payment.
• 40 hours/week.
• Flexible working hours.

The position is initially limited to 2 years, with the option to extend.