Summary
About the Role
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)
Essential Requirements:
- Functional Breadth.
- 1-3years experience in Pharma/Manufacturing sector in analytical lab in.
- Collaborating across boundaries.
- a GMP environment/equivalent.
Desirable Requirements:
- Good command of English language
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