Quality Assurance Consultant

Duration: 6–12 months (with potential extension)

We are currently supporting a leading pharmaceutical manufacturing organisation in France in the search for an experienced QA Consultant to support key Quality Assurance activities across technology transfer projects and visual inspection operations.

Key Responsibilities

• Provide Quality Assurance oversight for pharmaceutical technology transfer activities, ensuring compliance with GMP requirements and site quality standards.
• Review and approve technical transfer documentation, protocols, reports, risk assessments, change controls, deviations, and CAPAs.
• Support qualification and validation activities associated with process transfers, equipment implementation, and manufacturing readiness.
• Act as QA representative during project meetings, ensuring quality risks are identified, assessed, and appropriately mitigated throughout the transfer lifecycle.
• Provide QA oversight of manual and automated visual inspection processes for sterile products, including defect classification, inspection strategy, qualification, and continuous improvement initiatives.
• Review and approve visual inspection procedures, training records, validation documentation, and performance monitoring data.
• Support regulatory inspection readiness and client audits by ensuring robust documentation and compliance with EU GMP, FDA, and data integrity requirements.
• Collaborate closely with Manufacturing, Technical Services, Validation, Engineering, and Regulatory Affairs teams to ensure successful project delivery.

Requirements

• Significant experience within Pharmaceutical Quality Assurance in GMP-regulated environments.
• Proven experience supporting technology transfer projects from a QA perspective.
• Strong knowledge of visual inspection processes for sterile injectable products, including manual and automated inspection systems.
• Experience managing deviations, CAPAs, change controls, investigations, and risk assessments.
• Good understanding of Annex 1, EU GMP, FDA regulations, and data integrity requirements.
• Previous experience within CDMO, sterile manufacturing, or aseptic production environments is highly desirable.