SUMMARY

Establish and ensure testing of drug substance release and stability testing including all testing of intermediates in process. Control samples and lab operations are in accordance with written testing SOP’s and local/international regulations.

KEY RESPONSIBILITIES:

• 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 and personnel monitoring -Provide expert Support for site qualification and 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)
• Comply with all HSE guidelines
• Detect and report potential accident, risks and propose solutions
• Participate in HSE risk assessments
• Preparation and participation to internal HSE audits
• Responsible for participating in initial training and retraining