Quality Expert, Data Analytics and Statistical Support
Core
Ensure consistency and compliance of manufacturing processes by generating control charts for PQR and CPV reports and providing statistical support for investigations.
Role type
Quality Data Specialist (Statistical Support)
Builds
Periodic Quality Review (PQR) and Continued Process Verification (CPV) reports
Domain
Life Sciences / Pharmaceutical Manufacturing / GxP
Deliverable
dashboards & analysis
Required skills
Statistical software proficiency (Statistica, Minitab), Data integrity management, Root cause analysis, Complex data querying, Regulatory compliance knowledge (GxP/GMP)
Preferred skills
Experience in Quality or Manufacturing environments, Familiarity with LIMS and MES systems
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, hands-on IC
