Senior QA Engineer
Core
Provide independent quality oversight for Commissioning, Qualification, and Validation (CQV) activities for facilities, utilities, equipment, and systems in a GMP-regulated environment.
Role type
Senior QA Engineer (CQV)
Builds
Qualified facilities, utilities, manufacturing equipment, and laboratory systems for GMP use
Domain
Pharmaceutical/Biotechnology / Quality Assurance & Validation
Deliverable
client delivery
Required skills
GMP compliance, validation lifecycle knowledge, risk assessment, deviation management, CAPA, change control, data integrity, technical documentation review, P&ID interpretation
Preferred skills
Electronic validation systems (Kneat, ValGenesis, TrackWise)
Technologies
Kneat, ValGenesis, TrackWise
Responsibilities
Review and approve CQV deliverables (plans, protocols, reports), assess root-cause investigations and corrective actions, monitor closure of deviations and change controls, support internal audits and regulatory inspections, provide QA guidance during project design and execution.
Seniority
Mid-Senior level
