Sr QA officer (injectable products) - Orléans

Excelya is seeking a Senior Quality Assurance Officer to ensure the integrity and safety of their sterilization processes within clinical development. This role involves managing task lists, communicating with stakeholders, and ensuring compliance with industry standards and regulatory requirements. The role focuses on fostering a culture of continuous improvement and excellence.

Requirements

• Experience in sterility assurance and aseptic operations, ideally in the manufacturing of injectable products under isolator.
• Proven expertise in Contamination Control Strategy (CCS) and Aseptic Process Simulation (APS) implementation.
• Strong background in risk management, deviation investigations, and CAPA management within the pharmaceutical or medical device industry.
• Deep understanding of regulatory compliance, sterilization methodologies, and GMP requirements.
• Ability to lead and influence multidisciplinary teams and foster a culture of sterility excellence.

Benefits

• Young, ambitious health company
• Employee focused
• One-stop provider service
• Full-service, functional service, and consulting