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SpecialismQuality Assurance
Quality roles split into audit, systems and validation. We separate them early, because a strong auditor and a strong QMS owner are usually different people.
Roles we recruit
- GMP / GCP / GVP auditor
- QA manager
- QMS and CAPA owner
- Validation engineer (process, cleaning, computerised systems)
- Supplier quality specialist
- Data integrity specialist
Skills and systems we screen for
- Internal and vendor audits
- CAPA, deviations and change control
- Computerised system validation
- Data integrity (ALCOA+)
- eQMS tools (TrackWise, Veeva QMS, MasterControl)
- Inspection readiness
What we ask in the screening call
- Audits led versus supported
- Inspections hosted (agency, customer)
- Manufacturing or clinical focus
- Systems ownership
Regulatory frameworks
Reference points we use when briefing and screening.
- EU GMP / GDP
- FDA (21 CFR 210, 211)
- ICH Q-series
- WHO GMP