QA Officer
Core
Lead the site Product Quality Review (PQR) process and act as a Deviation Investigator for quality events in a GMP pharmaceutical manufacturing environment.
Role type
QA Operations Officer (Product Quality Review & Deviation Investigation)
Builds
Inspection-ready PQR reports, deviation investigation reports, CAPAs, and quality trend dashboards for commercial pharmaceutical products.
Domain
Pharmaceutical manufacturing / Quality Assurance / GMP compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> dashboards & analysis
Required skills
GMP regulations knowledge, data analysis and trending, root cause analysis, technical writing, cross-functional coordination, statistical tool usage
Preferred skills
Product Quality Review experience, pharmaceutical quality systems knowledge
Technologies
Excel, Minitab
Responsibilities
Manage the annual PQR schedule and coordinate data collection from multiple functions; Perform and author PQRs evaluating product/process performance data; Lead deviation investigations including root cause analysis and CAPA identification; Develop and report quality metrics and dashboards; Facilitate cross-functional review meetings and track action closure; Support regulatory audits and inspections.
Seniority
Mid-level, hands-on IC
