As Quality assurance specialist, you will be part of the Quality Assurance Department and will participate to all Quality Operations activities. Specifically :
- You will manage external and internal audits and be customer QA contact.
- You will provide day to day support to production and check compliance of production operation in order to assure the respect of the quality system in place and perform internal audits.
- You will assure the release of the API and KI batches within customer and management schedules and in accordance to the regulations (cGMP).
- You will participate to deviations investigations and coordinating corrective actions with manufacturing, and responsible for the management of major issues.
- You will check compliance of process and analytical documentation , including process validation/optimization.
- You will participate to change proposal assessments (change control related to process and batch records).
Our client offers an exciting role in a dynamic team as well as a chance to further develop your skills. A permanent contract with an attractive salary package and extra-legal benefits (insurance, lunch vouchers, bonus, etc.).