Spécialiste des systèmes qualité – Contrôle des changements / Quality Assurance Specialist - Change Control
Core
Coordinate and oversee the site Change Control process within TrackWise, ensuring changes are appropriately documented, risk-assessed, reviewed, approved, implemented, and closed in accordance with GMP and regulatory expectations.
Role type
Quality Systems Change Control Specialist
Builds
Pharmaceutical manufacturing quality systems and compliance
Domain
Pharmaceutical manufacturing / Quality Assurance
Required skills
Change control management, Risk assessment, GMP compliance, CAPA management, Deviation management, Validation lifecycle knowledge, Data integrity principles, eQMS platforms, Microsoft Office, SAP/ERP systems
Preferred skills
TrackWise experience, SAP experience
Technologies
TrackWise, SAP, Microsoft Office, eQMS
Responsibilities
Coordinate and manage change controls from initiation to closure, Review proposed changes for scope and impact, Collaborate with multidisciplinary teams, Monitor change control activities and timelines, Maintain accurate change control records, Provide training and guidance on change control processes, Support broader quality system activities including audits and inspections
Seniority
Mid-level, hands-on IC
