Laboratory Execution Systems IT Support Specialist
Vor 7 Tagen
We are seeking a highly skilled Laboratory Execution Systems IT Support Specialist to join our team at Vifor (International) AG. As a key member of our IT department, you will be responsible for ensuring the smooth operation of our Quality Control (QC) laboratory systems.
Key Responsibilities- Technical Support & Troubleshooting: Analyze and resolve hardware, software, and network issues specific to QC lab systems, ensuring minimal downtime and system performance.
- System Administration & Configuration: Configure, implement, and administer servers and applications used in QC labs, including VMWare and Citrix, to maintain a stable and responsive environment. Manage data backups and handle software updates.
- GxP Compliance & Quality Management: Oversee the qualification, GxP validation, and change management of QC lab systems. Ensure compliance with industry standards and regulatory requirements.
- Local Team Coordination: Act as the local coordinator for a small team of IT GxP specialists and project resources. Manage daily activities and coordinate closely with the Europe Lead for support and guidance.
- Collaboration & Process Improvement: Partner with QC Business Process Owners and Quality Assurance to facilitate system changes, conduct risk assessments, and implement enhancements and process improvements.
- Custom Solutions & Documentation: Develop and maintain customized scripts and configuration utilities for QC lab systems. Prepare and manage documentation related to system validation, SOPs, and compliance.
- Server & Data Management: Oversee validated servers and GxP Data Servers in QC labs, ensuring data integrity and availability. Assist with data retrieval and reporting.
- Compliance & Maintenance: Set up, configure, and maintain QC lab systems, adhering to industry standards. Perform emergency maintenance and system reviews to ensure GxP system health.
- University degree or equivalent vocational training in a relevant field, with 5+ years of experience in a regulated industry, including at least 3 years in a similar IT/CSV support role.
- In-depth understanding of the GAMP 5 framework and experience in creating qualification and validation-related documentation.
- Certifications (Beneficial): ITIL, Prince2, Microsoft MCSA, or Cisco CCNA.
- Experience with QC laboratory applications such as OpenLab, Chromeleon, Empower, UVWinLab, Spectrum, LabX, and NuGenesis.
- Familiarity with QMS systems like Veeva Vault and TrackWise.
- Experience with service support tools such as ServiceNow and asset inventory management tools.
- Thorough knowledge of Windows client operating systems (XP, 7, 10), server operating systems, Active Directory, storage and backup solutions, and network assets.
- Knowledge of server, storage, and virtualization standards, techniques, and tools. Experience with Acronis and CommVault is a plus.
- Proven experience in coordinating tasks and managing small groups effectively.
- Proven ability to effectively collaborate with peers, cross-functional teams, and users to ensure end-to-end product and process quality.
- Strong written and verbal communication skills in both German (level C1 CEFR) and English (level A2 CEFR) are essential.
- Availability to work full-time on-site at our office.
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