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Quality eSystem Specialist @ Alvotech

Reykjavik HeadquartersOnsiteFull-time
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About this role

Scope and responsibility:

• Provide Quality Systems expertise and support for GxP electronic systems across the organization. • Support the administration, configuration, maintenance, and continuous improvement of quality-related electronic systems, including Veeva Quality, Veeva LIMS, MasterControl, and other regulated platforms. • 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). • Support investigation, troubleshooting, and resolution of system-related issues in collaboration with business and technical stakeholders. • Participate in cross-functional projects focused on digitalization, process improvements, and quality system enhancements. Job requirements:

• University degree in pharmacy, biotechnology, chemistry, biology, engineering, computer science, information systems, or a related field. • Experience working in the pharmaceutical, biotechnology, or other regulated industries is desired. • Experience supporting or administering GxP computerized systems. • Working knowledge of Quality Management Systems and GMP requirements. • Experience with systems such as Veeva, MasterControl, LIMS, SAP, or equivalent enterprise platforms is considered an advantage. • Understanding of computerized system validation principles and data integrity requirements is beneficial. • Excellent communication and team working skills. • Strong attention to detail and commitment to quality. • Proficient English skills are required.

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