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- ...Process validation (IQ/OQ/PQ), sterilization, microbiology and biocompatibility knowledge Experience with Computer System Validation (CSV, GAMP 5), quality systems and IT/OT systems in manufacturing environments Supplier Quality Management and cooperation with...
- ...written and spoken English It is an advantage if you have experience with: LabVantage, LabWare, STARLIMS, or similar platforms CSV and validation documentation Integration technologies and data flows Customer facing consulting roles Agile project delivery...
- ...consultants arrive without any of them and build the expertise here. Experience with GxP compliance, computer system validation (CSV/CSA), or regulatory frameworks in life sciences Familiarity with AI/automation tools applied to enterprise transformation or operational...