Digital Quality Assurance Specialist

4 days ago


Stockholm, Stockholm, Sweden Sobi group Full time
Job Description

Sobi is a dynamic organization that aims to redefine the standards of care for people living with rare diseases. As a Quality Engineer and GxP e-Compliance Specialist, you will play a pivotal part in ensuring e-compliance and driving digital quality decisions through effective GxP system lifecycle management and quality data stewardship.

This role reports to our GxP e-Compliance Manager. The ideal candidate is proactive, ensuring compliance with Sobi standards through regular reviews, and adaptable, facilitating the integration of new GxP systems.

Key Responsibilities:
  • Ensure e-compliance through comprehensive GxP system lifecycle management, including acting as Business Admin for GxP systems (i.e. Veeva QMS, SQM, and training modules).
  • Drive the digital Quality roadmap and process quality automation across the GxP arena. Collaborate with cross-functional teams to identify opportunities for digital transformation and process improvements.
  • Oversee Quality Data Stewards to ensure adherence to relevant quality and regulatory requirements within the GxP field. Ensure efficient collection, processing, display, and storage of data, making it readily available for Quality Management review to facilitate prompt decision-making and reporting to health authorities and partners during audits and inspections.
  • Support the demands to maintain GxP learning processes and quality documentation processes, including owning procedural documents and global work instructions for GxP training, training matrix maintenance, and GxP governing documents.


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