Description
QC Stability Analyst
AstraZeneca implements and maintains a program of work designed to support the shelf life and quality of our products in market, and gain and retain our license in market. This program challenges the product quality at different climatic conditions over the life of the product in an annual maintenance cycle. The program also supports significant manufacturing and process changes.
The role
The job holder is responsible for ensuring compliance with AstraZeneca's commercial stability obligations.
The Stability Analyst is responsible for:
- evaluation and trending of stability data, performing stability technical assessments, maintaining overall surveillance of data/issues arising from the international commercial stability program
- Coordinate investigations of the supply chain of the affected products.
- Ensuring the integrity of stability study reports intended for submission to regulatory agencies and for providing expert stability knowledge and product overview for assigned products.
- Carrying out analytical method development
Requirements
The role demands an understanding of pharmaceutical stability testing and associated processes.
Minimum experience
- Masters Degree or equivalent experience and knowledge, chemistry or pharmaceutical sciences
- Knowledge/experience in analytical chemistry
- Excellent English communication skills, written and verbal
- Team working skills
- A proven number of years experience in the pharmaceutical industry within quality assurance, stability management or process technology, either from Operations or Research & Development
- Awareness of stability management processes, GMP demands and regulatory requirements in the area of stability testing.
- Experience of stability management processes, GMP demands and Regulatory requirements in the area of stability testing.