QA Validation Specialist
Core
Lead, coordinate, and perform validation/qualifications for equipment, facilities, systems, cleaning, and computer systems (CSV) to ensure site compliance and validated state.
Role type
QA Validation Specialist
Builds
Validated equipment, systems, and facilities for pharmaceutical operations
Domain
Pharmaceutical manufacturing / GMP compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP legislation knowledge, validation/CSV role experience, regulatory authority interaction, root cause analysis, deviation resolution, SOP authoring, cross-functional collaboration
Preferred skills
Engineering specification establishment, change control management, training delivery, audit/inspection support
Technologies
URS, SIA, VP, DQ, FAT, SAT, IQ, OQ, PQ, CSV, PV, VSR
Responsibilities
Lead and perform validation/qualifications for equipment and systems; Write and execute qualification documents (URS, SIA, VP, DQ, FAT, SAT, IQ, OQ, PQ, CSV, PV, VSR); Conduct root cause analysis and deviation resolution; Author SOPs for validation activities; Represent QA in cross-functional meetings; Champion validation training and materials.
Seniority
Individual Contributor
