Factory Acceptance Tests (FAT) participation at manufacturers sites (worldwide) for critical procurements (R&D, Manufacturing and Quality Control). Approvals release for FAT documents.
Site Acceptance Tests (SAT) organization & Training for all the processing systems included in the GMP areas
Drafting and/or Review of validation protocols: IQ/OQ and PQ for all the processing systems in a GMP facility (Post-harvest, Drying, Extraction, Refining, Purification, Formulation & Packaging).
Drafting and/or Review of validation protocols: IQ/OQ and PQ for all the systems in the laboratory.
Facility start-up activities support and systems finetuning. Service negotiation with manufacturers and release of final approvals.
Onsite training and remote with potential VR and AR custom made assets.
Optimization of systems operation, first trials with product, team, suppliers and subcontractors’ coordination with regards to final goals. Design & procurement of auxiliary equipment & materials.
Training of Scientific & Technical personnel on operations & R&D/QC. Writing of internal instructions and manuals. Planning of trials and training activities for optimal personnel qualification.
