CommunicationData integrityQuality assuranceCAPA managementProject management softwareSocial impact assessmentBatch record managementAdministrative process improvementUser instructionPharmaceutical developmentChange Control RecordsRegulatory Compliance in Medicine
Sprachen
DeutschEnglisch
Vergütung
03
Attractive salary package
Die Stelle
04
### Responsibilities ###
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
01Ensure compliance of the manufacturing processes, batch record, deviation, change control, CAPA
02Review and approve executed batch records within defined timeline
03Review and approval of operational elements such as procedures and related documents including specifications, working instructions, impact assessment.
04Respect and share data integrity rules (ALCOA+)
05Make proposals to improve flows, manufacturing activities, and organization
Anforderungen
↳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
