As QA Manager in the Quality Engineering department, you will ensure the GMP compliance of our production and analysis systems as well as infrastructure facilities and make a decisive contribution to the quality and growth of the Bachem Group.
Requirements
- - Responsibility for the GMP-compliant life cycle of production and analysis systems as well as infrastructure facilities
- - Approval and evaluation of requalifications, maintenance activities, technical change requests and deviations
- - Professional leadership of qualification and validation activities in projects (including CAPEX)
- - Review and approval of qualification documents (URS, DQ, IQ, OQ, PQ) as well as overarching validation documents
- - Creation and approval of GMP-relevant documents (SOPs, Logbooks)
- - Support during inspections by authorities and customer audits
- - Ensuring the GMP status of equipment and facilities through regular reviews
Benefits
- - A responsible expert role with direct influence on quality and compliance
- - Participation in strategic projects in an innovative, globally growing company
- - Flexible working time models, home office options and attractive social benefits
- - Varied opportunities for further education and development