05 ott - Porto Empedocle
Ceva Logistics
Industrial Development Technical leader
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Context
As part of the development of its activities, the Global Industrial Development department is recruiting an Industrial Development Project Manager (M/F) based in Porto Empedocle's plant (Italy). You will play a central role in the industrial transfer of strategic projects, particularly for new products and technology transfers, being responsible for implementing and overseeing the technical aspects of product manufacturing from the I&D; development phase through industrial launch, site transfers, and change control implementation.
Missions
Industrialization project management
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- Define and lead the industrialization strategy
- Contribute to process selection (Quality by Design approach)
- Coordinate I&D; and industrial teams (production, purchasing, quality assurance, quality control, maintenance)
- Write risk analysis,
protocols and reports for process optimization and validation, and review master batch record accordingly
- Monitor batch manufacturing in compliance with GMP and analyze results
- Ensure product compliance, EHS rules, projects cost and timeline adherence, integration of technical and regulatory updates
Technical support to the production site
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- Participate in supplier and process change validations
- Actively contribute to troubleshooting related to production processes
- Supervise galenic/industrial trials and risk analyses (FMEA).
Department activities
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- Contribute to drafting procedures, audits, inspections, and documentation follow-up.
Your profile
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- Master's degree (MSc, Engineering Degree, or equivalent) in biology, chemistry or pharmacy with at least 5 years of experience in the pharmaceutical industry in roles related to production systems.
- GMP rules
- Experience in project management and team coordination and/or transve
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