Quality Control & Processes
Know-how- Quality management :
- Project documentation and technical writing
- Project quality and quality management systems
- Qualification of equipment or utilities :
- Risk analysis (FMECA)
- Drafting DQ / IQ / OQ / PQ protocols
- Following protocol
- Writing reports
- Validation of computerised systems (CSV according to GAMP 5)
- Assembly and tuning, FAT, commissioning & SAT, follow-up and lifting of reserves
- Document management, certificate management