Overview
Quality Assurance Manager Jobs in Mont-Saint-Guibert, Walloon Region, Belgium at NOVADIP Biosciences S.A.
Title: Quality Assurance Manager
Company: NOVADIP Biosciences S.A.
Location: Mont-Saint-Guibert, Walloon Region, Belgium
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
