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

📌 Quality assurance manager (Mont)
🏢 NOVADIP Biosciences
📍 Mont