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
Full posting text
Quality Assurance Manager Responsible for supporting and maintaining the Quality Management System while ensuring compliance with internal procedures and GCP requirements. Employee or consultant. Key Responsibilities: Manage and maintain quality documents within the eQMS platform Scilife, including: -Training administration and follow-up -User support and helpdesk activities -Document lifecycle management -Force reviews and periodic reviews -Document & training exports and archival activities -Management of obsolete documents Review and support quality documentation related to: -Clinical operations activities -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. Participate in continuous improvement initiatives and support inspection and audit readiness activities. Key Skills: Quality Management Systems (QMS) Scilife Administration and Document Control In-depth knowledge of GCP Deviation and CAPA Management Internal Auditing IT Validation (CSV) is a plus Document Management and Training Systems Interested? Please use the button above email your CV together with an adapted cover letter to careers@novadip.com. Your application and related information will remain strictly confidential.