Quality IT Systems Administrator
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Job Description
Quality IT Systems Administrator at Bachem ensuring compliant and efficient operation of Quality IT Systems. Administering, supporting, and improving systems in a regulated environment.
Responsibilities:
- 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
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
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