Senior GMP Consultant – Sterile Manufacturing & FDA Inspection Preparation
6 month, full time B2B project
Scope of Support
• Act as a senior GMP advisor to the manufacturing team throughout FDA inspection preparation activities.
• Perform detailed assessments of current manufacturing processes and identify potential regulatory and compliance risks.
• Support the development and execution of improvement actions to remediate identified gaps and strengthen inspection readiness.
• Evaluate existing GMP documentation systems, including SOPs, batch documentation, manufacturing records, logbooks, and risk assessments, and recommend improvements where required.
• Provide expert input into the investigation and resolution of deviations, CAPAs, change controls, and OOS/OOT events with a focus on regulatory expectations.
• Ensure alignment of aseptic manufacturing practices with FDA requirements, EU GMP guidelines, and Annex 1 expectations.
• Conduct floor-based assessments within manufacturing areas and provide coaching to operational teams on GMP behaviours and inspection preparedness.
• Support the preparation of inspection-related materials, including briefing documents and presentations for internal readiness activities.
• Drive assigned CAPA activities independently, ensuring effective and timely completion.
