GMP Compliance Specialist m/f/d, AargauIn the role of GMP Compliance Manager, you will ensure that cGMP regulations and guidelines are taken into account in all our packaging, logistics and support processes of Team Operations. This also includes aspects of qualification and validation. This makes an important contribution to the quality of our products.
The perfect candidate has either a completed technical education with several years of professional experience in a GMP regulated, manufacturing company or a degree in life science or engineering with initial professional experience in a GMP regulated manufacturing company. Good knowledge of operating processes and facilities as well as change and deviation management is required. Also like the first professional experience in driving continuous improvement processes.
Tasks & Responsibilities: - Independent processing of GMP activities in the packaging plant
- Processing of deviations, planned events as well as CAPA etc.
- Creation and revision of documents such as SOPs and other process and plant-specific instructions
- Implementation of GMP training and further development of GMP knowledge of the employees of the clinical packaging company
- Support and/or management of projects in the GMP-regulated environment, e.g. in the
- Procurement of new equipment or systems as well as the implementation of new processes
- Close cooperation with interfaces such as engineering, quality, planning, logistics, etc.
Must Haves: - Either a completed technical education with several years of professional experience or a degree in the field of life science or engineering with initial professional experience
- At least initial professional experience in a cGMP production environment preferably in packaging and inspection or warehousing logistics processes
- Knowledge of cGMP standards
- Initial experience with internal (PTQ) or external (e.g. FDA, EMA) inspections
- Good technical understanding and the ability to understand and define processes
- Fluent in written and spoken German and English
- Knowledge of Google applications, computer programs MS Word/Excel/PowerPoint, Visio as well as systems such as SAP, cornerstone, Veeva
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