Sterile Production Specialist

Sanofi

Job Purpose:

Lead the ampoule manufacturing team to meet the provided production plan and assure complying of the process to the cGMP rules.

Responsibilities and Tasks:

Manufacturing and packaging operations in ampoule area.

• Oversee daily production operations and ensure compliance with GMP (Good Manufacturing Practice) standards.
• Monitor and optimize manufacturing efficiency while maintaining product quality.
• Follow SOPs (Standard Operating Procedures) and maintain proper documentation.
• Maintain accurate production records and documentation.
• Create and update batch documentation for sterile products.
• Make decisions on batch disposition in collaboration with Quality Assurance.
• Ensure proper gowning and aseptic behavior of all personnel in the sterile area.
• Ensure all critical parameters are met during manufacturing operations.
• Oversee and train production staff on sterile techniques and GMP requirements.
• Manage clean room classifications and maintain sterile conditions.
• Develop and maintain defect libraries and classification systems.
• Ensure consistent application of defect criteria across all inspectors
• Oversee the maintenance and qualification of manual inspection process
• Troubleshoot production issues and propose solutions.
• Maintain compliance to local and Sanofi regulations in sterile manufacturing and packaging areas.

New Ampoule projects area:

• Participate in validation and qualification activities for new line (IMA line, Fedegari autoclaves, Cleaning, Process, etc)
• Create SOPs for new ampoule area.
• Support internal and external audits
• Collaborate with cross-functional teams (Quality, Supply Chain, Engineering)
• Support regulatory requirements and documentation.
• Participate in multidisciplinary teams for problem-solving and continuous improvement

HSE and Energy Role:-

• Communicate information shared by the HSE team
• Share best practices.
• Monitor team HSE dashboard (KPIs of the area), ensure a global overview & consolidation (for example: track deployment of HSE programs, actions, events, investigations, inspections, trainings, risk assessment).
• Propose improvements.
• Promote HSE weak signals collection.
• Raise and alert if needed to concerned manager and/or to HSE team.
• Support managers on HSE topics.
• Organize immediate GEMBA in case of event involving the right people.
• Support/lead HSE investigations.
• Coordinate local drills.
• Coordinate coactivity in the area and associated GEMBAs.
• Maintain up to date chemical lists for the department & SMDS access
• Coordinate general HSE onboarding for newcomers
• Facilitate coordination of MSV in the area
• Attend HSE champions network meeting
• Support the HSE trainings on the shopfloor