Dieses Jobangebot ist archiviert und steht nicht mehr zur Verfügung.
Vakante Jobangebote finden Sie unter Projekte.
Vakante Jobangebote finden Sie unter Projekte.
SOP Systems Specialist (m/f)
Eingestellt von Hays aus Mannheim, Universitätsstadt
Gesuchte Skills: Client
Projektbeschreibung
- Implement and embed a Quality Management System (QUDOS) across client's company divisions. This includes significant reduction of global regulatory bound documentation (SOPs, work instructions and forms)
- Review of SOPs, Work Instructions and Forms to ensure that client procedural documents are compliant with GCP/PV regulations i.e. ICH GCP, EU & FDA regulations and inspection ready in the following areas across GCP/PV: Clinical Development including: Regulatory Affairs, Study Documentation e.g. Protocol, ISF, CSR, TMF. Study Management: IMP, Monitoring, Data Management & Stats etc.
- Clinical safety
- GCP / PV
- Quality Assurance including e.g. CAPA, Deviation, Training & Vendor Management
- Experience with pharma SOP system implementation required
- Ability to deliver against tight timelines
- Fluent English both written and oral
- Able to commence work in July
Weitere Qualifikationen: Quality manager
- Review of SOPs, Work Instructions and Forms to ensure that client procedural documents are compliant with GCP/PV regulations i.e. ICH GCP, EU & FDA regulations and inspection ready in the following areas across GCP/PV: Clinical Development including: Regulatory Affairs, Study Documentation e.g. Protocol, ISF, CSR, TMF. Study Management: IMP, Monitoring, Data Management & Stats etc.
- Clinical safety
- GCP / PV
- Quality Assurance including e.g. CAPA, Deviation, Training & Vendor Management
- Experience with pharma SOP system implementation required
- Ability to deliver against tight timelines
- Fluent English both written and oral
- Able to commence work in July
Weitere Qualifikationen: Quality manager
Projektdetails
Geforderte Qualifikationen
-
Kategorie:
IT Entwicklung