Ingénieur Assurance Qualité Environnementale H/F
Core
Lead environmental quality operations and team management for sterile injectable production in controlled environments.
Role type
Senior IC environmental quality engineer (pharmaceutical)
Builds
Sterile injectable aesthetic medicine products
Domain
Pharmaceutical manufacturing / Medical devices
Required skills
Team leadership, Environmental quality management, Cleanroom operations, Validation & verification, Risk assessment, Corrective action planning, Audit management, Documentation control, LIMS management, Training delivery
Preferred skills
Power BI, Data analysis
Technologies
LIMS, MS Office, Power BI
Responsibilities
Manage and lead a team of environmental sampling operators, Coordinate environmental sampling plans, Ensure compliance with group standards for clean zones and utilities, Collaborate with SME AQ on strategy deployment, Link with production and operational QA teams, Maintain cleaning process controls and training, Update LIMS control points, Conduct internal/external environmental audits, Evaluate risks for non-conformities, Implement corrective and preventive actions, Maintain activity documentation, Coordinate annual gas checks and bi-annual air change rate controls.
Seniority
Senior, hands-on IC with team management
