Quality Expert, Data Analytics and Statistical Support
Core
Ensure consistency and compliance of manufacturing processes by generating control charts for Periodic Quality Review (PQR) and Continued Process Verification (CPV) reports.
Role type
Quality Data Specialist (Statistical Support)
Builds
PQR and CPV reports for life-saving pharmaceutical products
Domain
Life sciences / Pharmaceutical manufacturing / GxP
Required skills
Statistical software proficiency (Statistica, Minitab), Data integrity management, Root cause analysis, Data querying, Regulatory compliance knowledge, Cross-functional collaboration
Preferred skills
Quality or Manufacturing environment experience (GxP/GMP), Life sciences background
Technologies
Statistica, Minitab, LIMS, MES
Responsibilities
Generate and interpret control charts for PQR and CPV reports, Ensure integrity of raw data within source systems, Communicate data excursions to stakeholders, Maintain control charting for production campaigns, Provide expert support for investigations using statistical tools, Collaborate with functional leads to validate data requirements
Seniority
Mid-Senior (5+ years experience)
