Quality Engineer and GxP e-Compliance Specialist

Vor 4 Tagen

Basel, Schweiz Sobi group Vollzeit
Quality Engineer and GxP e-Compliance Specialist
  • Full-time
  • Sobi Location: Sweden

Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application

At Sobi, the work we do every day redefines the standards of care and transforms the lives of people living with rare diseases.

As a diverse team of entrepreneurial people, we are passionate about our growth journey towards becoming a global leader, making a difference for rare disease patients, moving quickly and always challenging the status quo.

We are committed to an inclusive, sustainable, and flexible workplace that fosters growth and development.

As the Quality Engineer and GxP e-Compliance Specialist, you will play a pivotal role in ensuring eCompliance and driving digital quality decisions through effective GxP system lifecycle management and quality data stewardship. This role will support the company's vision of "Ensure eCompliance and Go digital to enable Quality decisions driven by data" by overseeing GxP systems and its data processed in GMP, GDP, GCP, and GVP fields and ensuring the lifecycle for appropriate governance and oversight. The specialist will also act as a business admin for Veeva QMS, SQM, and training modules.

The role reports to our GxP e-Compliance Manager.

Key Responsibilities

  • Ensure eCompliance 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.
  • Implement Sobi standards and verify compliance through periodic reviews. Ensure adherence to current GxP and Sobi requirements.
  • Support CSV activities (observing the segregation of duties), inspections, internal audits, follow-up activities, and remediation guidance.
  • Facilitate the streamlined integration of new companies and their GxP systems into our e-compliance framework by developing and implementing adaptive GxP processes.

We are seeking a detail-oriented professional to ensure eCompliance through robust GxP system management and data stewardship. Strong analytical skills are required to drive digital quality initiatives and identify process improvements. Effective communication is essential for cross-functional collaboration and supporting GxP documentation. The ideal candidate is proactive, ensuring compliance with Sobi standards through regular reviews, and adaptable, facilitating the integration of new GxP systems.

Key Qualifications

  • Documented education in Natural science, chemistry, pharmacology, pharmaceutical development, IT, or corresponding work experience within IT and/or the GxP area/areas.
  • 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.
  • Experience with digital transformation initiatives and process automation in the pharmaceutical industry.
  • Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
  • Fluent in English (written and oral).

Why Join Us?

  • Emphasis on work/life balance
  • Collaborative and team-oriented environment
  • Opportunities for professional growth
  • Diversity and Inclusion
  • Competitive compensation for your work
  • Making a positive impact to help ultra-rare disease patients who are in need of life-saving treatments
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