The client is a world leader in the life sciences, operating on three continents. The most important scientific solutions is talented people who work together and develop ideas that help other companies to help people. In return, our employees manage their careers independently, because their ideas, big and small, make the world a better place.
Key responsibilities:
- Represent the Phys-Chem QC department in audits and inspections
- Coordinate activities for audits and inspections, including preparation and coordination of pre-audit and post-audit measures
- Coordinate the timely finalization of deviations, CAPAs and changes
- Support the creation and handling of deviations including root-cause analysis and definition of CAPAs
- Support the creation, planning, and execution of CAPAs and changes
- Execute efficiency tests of CAPA measures
- Support Track & Trend analysis of deviations
Key requirements:
- PhD or MSc in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related field
- Extensive working experience under cGMP regulations in Quality Control or Quality Assurance
- Sound knowledge of international guidelines, e.g. ICH, PIC beneficial
- Very good communication and planning skills
- Excellent knowledge of quality systems
- Ability to work independently and in a team environment
- Excellent knowledge of written and spoken English