QA Expert / Senior QA Specialist Instrument Qualification, DPS 80-100%
Core
Establishing and maintaining the Equipment Qualification System for computerized lab instruments and systems in a GMP-regulated environment.
Role type
Senior QA Specialist (Instrument Qualification)
Builds
Qualified equipment, instruments, and computerized systems for drug product manufacturing.
Domain
Life Sciences / Pharmaceutical Manufacturing / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Equipment qualification system management, GMP compliance, document lifecycle management, change control, deviation/CAPA management, audit participation, training plan development
Preferred skills
ISPE GAMP5 knowledge, USP 1058 knowledge, LIMS/DMS/Trackwise/SAP/ELN usage
Technologies
LIMS, DMS, Trackwise, SAP, ELN
Responsibilities
Execute establishment and maintenance of Equipment Qualification System; ensure proper qualification of equipment/instruments/computerized-systems; act as first contact for equipment qualification & maintenance; manage document life cycle for qualification protocols and reports; handle compliance issues in shared global systems; supervise and execute compliance activities (non-conformities, deviations, CAPAs, audits); establish and implement training and development plans
Seniority
Senior, hands-on IC
