Ensure compliance of the manufacturing processes, batch record, deviation, change control, CAPA
Review and approve executed batch records within defined timeline
Review and approval of operational elements such as procedures and related documents including specifications, working instructions, impact assessment.
Respect and share data integrity rules (ALCOA+)
Make proposals to improve flows, manufacturing activities, and organization
Profile
Pharmacist or scientist with a master-s degree or equivalent experience
Solid experience in the pharmaceutical industry (biotech company) and commercial batch release
Knowledge of pharmaceutical manufacturing processes with a focus on biologic drug substances
Proficient communication (oral and written) in German and English
Experience in SAP and electronic MES (manufacturing execution system) is an asset