
Regulatory Affairs Coordinator
15 hours ago
This Quality Assurance Specialist position will play a critical 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.
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.
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