What qualifications you should bring to the job
With immediate effect we are looking for a:
Computer Systems Validation (CSV) - Support Analyst
Your tasks :
- Assisting with qualification activities for laboratory systems in a GxP Environment;
- Preparing and executing IT-related qualification documents (IQ/OQ);
- Performing compliance evaluations for PC hardware and software to ensure alignment with regulatory standards such as FDA 21 CFR Part 11 and EU Annex 11;
- Evaluating instrument software and managing software installation qualifications;
- Serving as the point of contact for IT and compliance within the laboratory systems framework;
- Supporting the development of standard operating procedures (SOPs) and work instructions.
Your Qualifications:
- Background in the pharmaceutical sector or relevant experience;
- Strong understanding of computer system validation (CSV), GAMP 5, and V-Model;
- IT expertise or a strong interest in IT Systems;
- Analytical mindset with a structured and independent approach to work;
- Excellent communication skills and ability to collaborate with various Stakeholders;
- Proficiency in German and English (written & spoken).
We offer you:
- A supportive and diverse team with an international Mindset;
- A collaborative and relaxed work environment;
- Flexible working hours to support work-life balance;
- Engaging and dynamic tasks with room for growth;
- The opportunity to work on exciting projects;
- Annual team events to celebrate success together;
- Competitive salary with performance-based bonuses.
Are you interested?
If you would like to apply directly, you can send us your CV by email or send us your details via the online application offered. When applying online, you can upload your CV after entering your contact details. This only takes 1 minute.