Digital Quality Engineer

14 hours ago


Stockholm, Stockholm, Sweden Sobi - Swedish Orphan Biovitrum AB (publ) Full time
Job Summary

This role will play a key part in ensuring eCompliance and driving digital quality decisions through effective GxP system lifecycle management and quality data stewardship.

The ideal candidate will have a strong background in GxP compliance, quality assurance, or a related field, with experience working in the pharmaceutical industry.

Main Responsibilities
  • Manage GxP Systems to ensure eCompliance through comprehensive GxP system lifecycle management.
  • Identify Opportunities for process improvements and quality automation across the GxP arena, collaborating with cross-functional teams.
  • Oversee Quality Data Stewards to ensure adherence to relevant quality and regulatory requirements within the GxP field.
  • Support CSV Activities, inspections, internal audits, follow-up activities, and remediation guidance.

Requirements

  • Documented education in Natural science, chemistry, pharmacology, pharmaceutical development, IT or corresponding work experience within IT and or the GxP area.
  • Minimum of 5 years of experience in GxP compliance, quality assurance, or a related field within the pharmaceutical industry.
  • Strong knowledge of GxP processes and computerized system validation (CSV) standards.
  • Experience with digital quality systems and tools, including Veeva QMS, SQM, and training modules.
  • Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.


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