Commissioning, Qualification & Start-Up
- 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.
- Staffing on facility critical operations –R&D, QC, QA, Manufacturing- personnel: Job descriptions, CV screening, Interview participation.