Position Overview
Roles & Responsibilities :
Monitor due dates for lab instrument reviews and coordinate with stakeholders. Execute SOP-driven validations, produce IQ/OQ/PQ deliverables, and ensure ALCOA+ data integrity. Perform gap analyses, remediation plans, and efficiency enhancements for lab operations. Report metrics on validation status, closures, and compliance to internal teams. Coordinate system changes with QA/equipment owners, author validation protocols, and complete change documentation. Track periodic instrument reviews using schedulers, generate RTMs/VSRs, and finalize compliance artifacts. Lead team task assignments, deliver validation training, and drive multi-site demand planning for GMP upkeep. Education & Experience: Minimum years in GxP/analytical lab settings with hands-on validation of GMP instruments including HPLC, , UV-VIS, FTIR, NMR, Polarimeter, XRD, Kaye Validators, and LIMS/Empower sys...