Quality Assurance Specialist CSV
Vor 6 Tagen
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.
Our team is passionate about making animals' lives better, and we're looking for a skilled professional to join us in this mission.
The ideal candidate will have a strong background in quality assurance and validation of computerized systems, with experience in the pharmaceutical GMP environment.
Responsibilities will include:
- Ensuring the GMP status and regulatory compliance of computerized systems throughout their lifecycle
- Validating computerized systems and verifying global system applications at the site
- Collaborating with the global CS validation team
- Analyzing and managing data
- Implementing quality assurance-related activities
- Conducting self-inspections
- Handling deviations, changes, and root cause analyses
- Creating quality-related documents (SOP, risk analysis, etc.)
- Reviewing and approving documents according to SOP guidelines
- Ensuring good documentation practices according to GMP
- Implementing operational excellence management and a culture of continuous improvement, as well as establishing measures to prevent incidents
- Participating in function- and department-crossing projects
Requirements:
- Completed natural science or technical studies or equivalent qualification
- Comprehensive knowledge and experience in the validation of computerized systems, as well as experience in the pharmaceutical GMP environment, particularly in quality assurance
- Excellent written and verbal communication skills (German and English)
- Ability to work independently, responsibly, and solution-oriented, flexibility, and analytical thinking
- Initiative and willingness to take on 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
We offer:
- An interesting and varied working environment in a modern and growing global company in the pharmaceutical industry
- Freedom for 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.
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