Posted 1 day ago
Quality eSystem Specialist
ReykjavikOn-siteFull-time
AI Summary
Provides Quality Systems expertise and support for GxP electronic systems, including administration, configuration, validation, and continuous improvement of regulated platforms.
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.
Skills
Computerized System ValidationData IntegrityGMPMasterControlQuality Management SystemsSAPSystem AdministrationUser Acceptance TestingVeeva LIMSVeeva Quality
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