Your key responsibilities in this role are:
- Conduct routine analytical testing, method qualification execution as well as stability in an independent manner on:
- Liquid chromatography (PA, SEC, RP,…)
- Capillary Electrophoresis (icIEF, CGE-SDS)
- Able to validate/qualify analytical methods (LC, CE especially, but knowledge of OD, LC-MS, ELISA can be an asset)
in GMP environment
- Deliver data treatment/elaboration and analytical reports of high quality in a digitally agile manner.
- Interact with customers when needed, with the aim of result discussion or coordination of routine and/or validation activities.
- Works autonomously for the execution of either routine or non-routine activities within established procedures and practices that require knowledge of technical concepts or specialized technical expertise, i.e stability.
- Strong expertise in GMP environment.
- Validate GMP methods including analysis and documentation. Method validation knowledge is mandatory.
- Actively seeks, shares and re-applies knowledge in own field of activities.
- Actively recommends and leads analytical workflow improvement initiatives in a cross functional setting.
- Presents and defends relevant topics during health authority inspections.
- Ability to write GMP documentation: URS, protocols, reports, working instructions, deviations, CAPA, CCP Actions.
