Tasks

- Commissioning and qualification of laboratory systems
- Representative of Quality in the CAPEX project organization in regards to qualification of lab systems
- Write and review SOPs and other qualification documents
- Ensure GMP requirements are fullfilled
- Review qualification/validation documents (URS, DQ/IQ/OQ/PQ Plans and Reports)
- CAPA & deviations
- Represents QA during the various project phases
- Represent qualification/validation topics during audits and inspections

Qualifications

- Bachelor, Master degree or PhD in relevant area
- Significant experience in the GMP regulated area especially cGMP
- Broad knowledge in qualification of laboratory equipment and systems
- Experience in interaction with regulatory agencies (e.g. Swissmedic and FDA)
- Fluent in English and German