Quality eSystem Specialist
Alvotech · Reykjavik
Job description
About the role
We are looking for a Quality eSystem Specialist to provide expertise and support for GxP electronic systems across the organization. The role involves administration, configuration, maintenance and continuous improvement of regulated quality platforms.
Key responsibilities
- Provide Quality Systems expertise and support for GxP electronic systems across the organization.
- Administer, configure, maintain and continuously improve quality‑related electronic systems such as Veeva Quality, Veeva LIMS and MasterControl.
- Design, create, verify and maintain system master data and data structures to ensure data integrity and regulatory compliance.
- Support implementation of new functionality, system enhancements and introduction of new electronic solutions.
- Execute and support system validation activities, including testing, verification and User Acceptance Testing (UAT).
- Investigate, troubleshoot and resolve system‑related issues in collaboration with business and technical stakeholders.
- Participate in cross‑functional projects focused on digitalisation, process improvements and quality system enhancements.
Required profile
- University degree in pharmacy, biotechnology, chemistry, biology, engineering, computer science, information systems or a related field.
- Experience supporting or administering GxP computerized systems, preferably in pharmaceutical or biotechnology environments.
- Working knowledge of Quality Management Systems and GMP requirements.
- Understanding of computerized system validation principles and data‑integrity requirements.
- Excellent communication, teamwork, attention to detail and strong commitment to quality.
Required skills
- Veeva Quality
- Veeva LIMS
- MasterControl
- LIMS
- SAP
- GxP computerized systems
- Computerized system validation
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Published 1 dagur síðan
Expires 1 mánuður síðan
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Alvotech
Reykjavik
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