Beschreibung
We need for a client an experienced CSV Manager.
Required skill set:
- Review of CSV deliverables for standard applications in line with CSV framework from client
- Experience in pharmaceutical industry
- Language: German and English (majority of documents are in German, global ones in English)
- Requested commitment
• Bulk production and packaging
• Toll Manufacturing for generics and originators
• No chemical production
• Supporting customers in clinical phase II with supply, analytics and project management
- Client operates with own application and infrastructure since Jan. 1st 2015
- Current workforce: ~50 employees
- Application scope for CSV
- Electronic Workplaces (Dell hardware with MS Office 2010 and Windows 7 Professional)
- SAP ECC (EHP7 FOR SAP ERP 6.0)
- Waters Empower
- Relationale Database systems (for example DMS)
- General measurement systems for laboratory
- Network infrastructure based on CISCO equipment
- IT Setup
- Basic infrastructure (data center, networks) are outsourced to local 3rd party provider (GIA). Supported by GIA and NetCloud
- Electronic Workplaces are owned and operated by client (full time internal IT Operations Engineer)
- Super-User-Organization for IT applications in place
- SAP support by local external consulting companies (resources were already on board for system setup )
- Service level agreements in place for all IT components and applications
- Hand-Over
- Comprehensive CSV framework in place (SOP, templates)
- Internal CSV manager will leave by Nov. 30th (1 month of hand-over)
- Parts of his responsibility for equipment and vendor qualification will be internalized. External support required for CSV activities
- Others
- FDA audit scheduled for 04. – 08. Dec. 2017
- Full-time onsite support required in this period
- All audits by RHI (SwissMedic), Anvisa, KFDA in the last years passed w/o major findings.
- 2 days per week
- Start: Nov. 1st 2017
- Duration: 5 month
- Kanton Aargau, Switzerland
Mit freundlichen Grüßen / Kind regards,
Kiran Kotla
Javaji Softech GmbH & Co. KG
www.javaji.de
Mammolshainer Weg 14
61462 Königstein im Taunus
Fon:
Fax:
Email :
HRA 3448 Amtsgericht Königstein, St.-Nr.
Persönlich haftende Gesellschafterin: Indra Enterprises GmbH, vertreten durch Krishna Javvaji
HRB 5137 Amtsgericht Königstein, St.-Nr.