Quality IT Systems Administrator

Role Overview

• Administer and operate assigned Quality IT Systems according to the applicable processes, ensuring availability, performance and compliance
• Perform user and role management, system maintenance and supports in system configuration & validation activities
• Support release and upgrade activities in coordination with the Quality IT System Owner
• Monitor system operation and ensure incident resolution in line with IT Service Management processes
• Collaborate closely with Business Owners and Business Administrators to support business processes in alignment with the Quality IT System Owner
• Translate approved business and system owner requirements into system configurations and operational setups
• Provide expert system support for Quality and Regulatory Affairs users
• Support compliance of Quality IT Systems with applicable GxP regulations and internal standards
• Contribute to validation and change documentation (e.g. risk assessments, testing support)
• Ensure systems remain inspection ready and compliant with the applicable regulations (e.g. data integrity, GxP, GDPR, etc.)
• Support audits and inspections together with Quality IT System Owner and Quality stakeholders
• Handle incidents, service requests and changes for Quality IT Systems
• Support root cause analysis and corrective actions related to system issues
• Ensure proper documentation and traceability of changes and system activities
• Identify opportunities for operational improvements and system optimization
• Support the implementation of best practices for Quality IT Systems administration
• Stay up to date with the supported system’s capabilities to advance system evolution and usability

Requirements

• Bachelor’s degree or equivalent experience in Information Technology, Life Sciences or a related field
• Experience in administering IT systems in a regulated (GxP) environment
• Practical experience with Quality IT Systems and platforms is preferred, such as: Veeva Vault (Veeva Vault Quality and/or RIM), Kneat, Gx, DocuSign (GxP relevant use cases)
• Solid understanding of CSV / CSA, GxP compliance and data integrity principles
• Experience with IT Service Management processes (e.g. ITIL)
• Structured, quality focused and reliable working style
• Strong communication and collaboration skills
• Fluency in English; German is an advantage

Tech Stack

• ITSM
• Vault

Benefits

• Flexible working hours with home office days and an option for obtaining additional vacation days through workload reduction
• Company‑run daycare center on the Bachem Campus in Bubendorf
• 60% coverage of pension fund contributions by Bachem AG as well as option for extra-mandatory pension provision with our Pension Plan Plus
• Access to benefits platforms with discounts from external partners
• Fresh, healthy and varied food in our staff restaurant
• A wide range of free sports activities on the Bachem Campus