IT Compliance and Computer System Validation Specialist | Informatiker/in (Hochschule)
OCTAPHARMA Pharmazeutika Produktions GmbH
Job Summary
As an IT Compliance and CSV Specialist, you will serve as a subject matter expert for computer system validation (CSV) and IT compliance within local projects. Your day-to-day responsibilities include performing periodic reviews of local IT systems, supporting the qualification of IT infrastructure, and actively participating in IT change management from a quality perspective. You will represent the IT department during internal and external audits, as well as regulatory inspections, focusing on data integrity and CSV processes. Additionally, you will manage IT Standard Operating Procedures (SOPs) and coordinate training for various departments. This role is ideal for professionals with a background in Computer Science or Law who have experience in the pharmaceutical industry. The position offers a stable environment within the 'Finance & IT' division of a global company, featuring a competitive salary and comprehensive benefits including professional development and health initiatives.
Required Skills
Education
Completed degree or training in Computer Science and/or Law (University/Higher Education level).
Experience
- At least 3 years of professional experience in validation and project management
- Professional experience in the pharmaceutical industry environment preferred
- Demonstrated experience with GxP regulatory requirements and data integrity standards
- Experience in managing IT processes and infrastructure qualifications
Languages
Additional
- The role requires the ability to represent the department during official regulatory inspections and audits. Located in Vienna, Austria (based on URL context).
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