Experience Senior · 6+ yrs (5+ years)
About the role
structured by ORIQuality Assurance Manager Responsible for supporting and maintaining the Quality Management System while ensuring compliance with internal procedures and GCP requirements. Employee or consultant.
What you will do
- Manage and maintain quality documents within the eQMS platform Scilife
- Review and support quality documentation related to clinical operations activities and internal audits
- Manage and coordinate deviations related to clinical operations and audit activities, including investigation support, root cause analysis, CAPA follow-up, and effectiveness verification
- Provide Quality Assurance support and guidance to Clinical Operations to ensure compliance with applicable GCP and internal quality requirements
- Contribute to IT validation activities (approximately 10% of workload), including documentation review, validation support, and compliance oversight
What they are looking for
- Quality Management Systems (QMS)
- Scilife Administration and Document Control
- In-depth knowledge of GCP
- Deviation and CAPA Management
- Internal Auditing
- Document Management and Training Systems
Nice to have
- IT Validation (CSV) is a plus
Before you apply
- Email your CV together with an adapted cover letter to careers@novadip.com.
Quality Management SystemsGCPDeviation and CAPA ManagementInternal AuditingIT ValidationDocument ControlScilife
Full posting text
Responsible for supporting and maintaining the Quality Management System while ensuring compliance with internal procedures and GCP requirements.