Team Member - QA Validation
Core
Review and approve qualification protocols, reports, and documentation for facilities, areas, equipment, and utilities to ensure compliance with quality management systems in pharmaceutical manufacturing.
Role type
Senior Quality Assurance Validation Specialist
Builds
Compliance with quality standards for manufacturing facilities and equipment
Domain
Pharmaceutical Manufacturing / Quality Assurance
Deliverable
dashboards & analysis
Required skills
Review of qualification protocols (URS, DQ, IQ, OQ, PQ), Smoke study protocols, VMP management, Change controls, CAPA handling, GMP compliance, Audit trail review, Calibration certificate review, Cleaning validation, GEMBA walks, Annual review of utilities
Preferred skills
Experience with BMS & EMS systems, SAP DocuSign, e-VAL, DocHub
Technologies
SAP, DocuSign, e-VAL, DocHub
Responsibilities
Review qualification protocols and reports for facility, area, equipment, and utilities; Review and approve smoke study protocols; Manage VMP and re-qualification calendars; Handle quality management system closure including change controls and CAPA; Participate in incident investigations; Prepare and review SOPs; Conduct GEMBA walks in utility systems; Compile annual reviews of utilities reports.
Seniority
Senior, hands-on IC
