Manufacturing Consultant
Discover International · Ingolstadt, Bayern ·
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.