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Quality Assurance Specialist
4 hours ago
At Sobi Group, we are committed to providing high-quality products and services to patients with rare diseases. We are seeking a highly skilled Quality Assurance Specialist to join our team.
The ideal candidate will have a strong background in quality assurance and regulatory affairs, with experience in GxP compliance and digital quality systems. The successful applicant will be responsible for ensuring that all company activities meet the required standards of quality and regulatory compliance.
Key Responsibilities:
- Ensure eCompliance through comprehensive GxP system lifecycle management.
- Drive the digital Quality roadmap and process quality automation across the GxP arena.
- Oversee Quality Data Stewards to ensure adherence to relevant quality and regulatory requirements within the GxP field.
- Implement Sobi standards and verify compliance through periodic reviews.
Required Skills and Qualifications:
- Documented education in Natural science, chemistry, pharmacology, pharmaceutical development, IT, or corresponding work experience within IT and/or the GxP 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 transformation initiatives and process automation in the pharmaceutical industry.
Benefits:
- Competitive compensation for your work.
- Making a positive impact to help ultra-rare disease patients who are in need of life-saving treatments.
At Sobi Group, our mission and culture get us excited to come to work every day, but here are a few more reasons to consider joining our team:
- Emphasis on work/life balance.
- Collaborative and team-oriented environment.
- Opportunities for professional growth.
- Diversity and Inclusion.
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