Quality Engineer and GxP e-Compliance Specialist
Company Description
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.
Job Description
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 Goes digital to enable Quality decisions driven by data" by overseeing GxP systems and its data processed in GMP, GDP, GCP, and GVP fields to ensure 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.
* Support the demands to maintain GxP learning processes and quality documentation processes, including owning procedural documents and global work instructions for GxP training.
* Implement Sobi standards and verify compliance through periodic reviews. Ensure adherence to current GxP and Sobi requirements.
* Support CSV activities, 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.
Qualifications
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.
Key Qualifications
* 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.
* Fluent in English (written and oral).
Additional Information
At Sobi, we value work-life balance and due to the holidays, it may take a little bit longer until you hear back from us. We have an ongoing selection process in this recruitment and ask you to send your application as soon as possible. Click apply and include your resume in English.
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.
We are a global company with over 1,800 employees in more than 30 countries and are committed to the societies where we operate.
Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Quality Assurance
Industries: Pharmaceutical Manufacturing
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