Quality Assurance Consultant – Pharmaceutical (Freelance)

About the role

We are supporting a leading pharmaceutical manufacturing organisation in France and are looking for an experienced Quality Assurance Consultant to oversee technology transfer projects and visual inspection operations on a freelance basis.

Key responsibilities

• Provide QA oversight for pharmaceutical technology transfer activities, ensuring compliance with GMP and site quality standards.
• Review and approve technical transfer documentation, protocols, reports, risk assessments, change controls, deviations and CAPAs.
• Support qualification and validation activities linked to process transfers, equipment implementation and manufacturing readiness.
• Act as the QA representative in project meetings, identifying and mitigating quality risks throughout the transfer lifecycle.
• Oversee manual and automated visual inspection processes for sterile products, including defect classification, inspection strategy, qualification and continuous improvement.
• Review and approve visual inspection procedures, training records, validation documentation and performance monitoring data.
• Assist with regulatory inspection readiness and client audits, ensuring compliance with EU GMP, FDA and data‑integrity requirements.
• Collaborate closely with Manufacturing, Technical Services, Validation, Engineering and Regulatory Affairs teams.

Required profile

• Significant experience in Pharmaceutical Quality Assurance within GMP‑regulated environments.
• Proven experience supporting technology transfer projects from a QA perspective.
• Strong knowledge of visual inspection processes for sterile injectable products, both manual and automated.
• 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 in CDMO, sterile manufacturing or aseptic production is highly desirable.

Required skills

• GMP compliance
• EU GMP knowledge
• FDA regulatory knowledge
• Visual inspection systems (manual and automated)
• Technology transfer documentation
• Deviation and CAPA management