QC Analyst At Novartis
Job Description
-OOx/Deviation handling . -CAPA definition -KPI trending -Ensure all activities in compliance with cGxP, incl. data integrity review and approval of analytical data / tests (analytical release) Stability -Stability testing (Projects) – protocol preparation, evaluation, report preparation . -Reporting (Stability plan preparation, trend analysis, evaluation) -Performance of Stability studies, protocols and comparative reports for supplier qualification -Review and approval of analytical tests (analytical release) -Microbiological QC -Perform Microbiological testing of materials and utilities, environmental & personnel monitoring -Provide expert Support for site qualification & validation activities -Maintain and calibrate equipment incl. plan preparation -Support in supplier qualification -Trending and analysis of KPI/KQI -Support sample planning and sampling execution -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)
Minimum requirements
Collaborating across boundaries Functional Breadth 0-3 years experience in Pharma/Manufacturing sector in analytical lab in a GMP environment/equivalent English Laboratory Excellence Laboratory equipment Quality Control (QC) Testing Quality Control Sampling Quality decision making Knowledge of IT Applications & tools Knowledge of TQM and related industry GxP standards and processes
Division
Novartis Technical Operations
Business Unit
NTO QUALITY
Country
Egypt
Work Location
Cairo
Company/Legal Entity
NOV PHARMA EGY
Functional Area
Quality
Job Type
Full Time
Employment Type
Regular
Shift Work
No
Early Talent
Yes