Sterility Assurance & Aseptic Processes Expert (Injectables)

About the role

We are seeking a Sterility Assurance & Aseptic Processes Expert to lead our clients’ sterility strategies for injectable products. The role involves guiding the implementation of Controlled Contamination Zones (CCS) and Aseptic Processing Systems (APS) while ensuring compliance with regulatory standards.

Key responsibilities

• Develop and lead sterility assurance strategies and CCS/APS implementation.
• Conduct risk analyses, including initiation, execution, and CAPA follow‑up.
• Draft scientific justifications, protocols, reports and SOPs.
• Perform gap analyses against GMP Annex 1 and Annex 13.
• Support regulatory inspections and prepare CCS documentation.

Required profile

• Confirmed (5–7 years) or expert (10+ years) experience in sterility assurance for injectables.
• Fluent in French and English.
• Ability to work autonomously, with strong analytical and relationship skills.
• Willingness to travel across France as needed.

Required skills

• GMP Annex 1 compliance.
• Sterile operations and aseptic filling under isolator.
• Risk management methodologies (AMDEC, deviation handling, change control).
• Regulatory knowledge of EMA and FDA requirements.